0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Article |

Deep Sedation With Propofol by Nonanesthesiologists:  A Prospective Pediatric Experience FREE

Egidio Barbi, MD; Tania Gerarduzzi, MD; Federico Marchetti, MD; Elena Neri, MD; Elena Verucci, MD; Irene Bruno, MD; Stefano Martelossi, MD; Giulio Zanazzo, MD; Armando Sarti, MD; Alessandro Ventura, MD
[+] Author Affiliations

From the Clinica Pediatrica (Drs Barbi, Gerarduzzi, Marchetti, Neri, Verucci, Bruno, and Ventura), Servizio di Gastroenterologia (Dr Martelossi), Servizio di Emato-Oncologia (Dr Zanazzo), and Servizio di Anestesia e Rianimazione (Dr Sarti), Istituto di Ricovero e Cura a Carattere Scientifico Burlo Garofolo, University of Trieste, Trieste, Italy.


Arch Pediatr Adolesc Med. 2003;157(11):1097-1103. doi:10.1001/archpedi.157.11.1097.
Text Size: A A A
Published online

Background  The need to perform procedural sedation for children has increased in recent years, and so has the experience of nonanesthesiologists in this field. The use of propofol increases the success of satisfactory deep sedation, but it can produce rapid and profound decreases in level of consciousness and cardiorespiratory function. Data are needed to assess the safety of this drug outside an anesthesiology setting.

Objective  To assess safety and efficacy of procedural sedation with propofol in a pediatric ward of a tertiary-care pediatric teaching hospital with trained personnel and monitoring facilities.

Methods  Patients admitted to the hospital who needed invasive procedures underwent procedural sedation by the pediatric sedation unit with intravenous propofol. A training protocol was developed to educate nurses and residents.

Results  We performed 1059 procedures. Sedation was achieved in all procedures, and all but 1 were successfully performed. No patient required intubation. Transient desaturation resolving spontaneously occurred in 134 (12.7%) of 1059 patients. Major desaturation requiring a short course of ventilation occurred in 4 (0.8%) of 483 patients undergoing upper endoscopies, in 1 (0.3%) of 287 patients undergoing painful procedures, and in none of the 289 patients undergoing colonoscopies. Laryngospasm occurred in 10 (2.1%) of 483 patients undergoing upper endoscopies.

Conclusions  In this experience, the use of propofol with concurrent oxygen administration allowed sedations in children with no significant complications for colonoscopies and painful procedures. Complications in the group of upper endoscopies appear too high for recommending propofol in a sedation unit with residents in attendance. This protocol of procedural sedation by nonanesthesiologists allowed a significant increase in the number of procedures performed with sedation and saved anesthesiology resources.

WIDESPREAD availability of noninvasive monitoring, short-acting opioids and sedatives, and specific opioids and benzodiazepine antagonists have enabled clinicians to administer sedation safely for procedures in diverse settings.1,2

Intravenous ultra–short-acting agents (etomidate, methohexital, propofol, remifentanil hydrochloride, and thiopental sodium) are an attractive option for procedural sedation, because the dosage can be rapidly titrated to produce the desired depth of sedation and recovery is very rapid. However, with these drugs, inadvertent oversedation and rapid swings in consciousness are more likely, with rapid and profound decreases in level of consciousness and cardiorespiratory function, especially when they are administered by clinicians with limited training and experience in their use.15 Therefore, further research is important to clarify the safety profile of these drugs and to determine the settings in which nonanesthesiologists may administer them. The aim of this prospective study was to assess the safety and efficacy of procedural sedation with propofol in the pediatric ward of a tertiary pediatric teaching hospital with trained personnel and monitoring facilities for a period of 36 months.

From September 1, 1999, with the agreement of the departments of pediatrics, anesthesia, gastroenterology, and oncology at the University Pediatric Hospital of Trieste, Trieste, Italy, a new sedation protocol was introduced, with the development of a pediatric sedation unit (PSU).

A team was organized for pediatric sedation, consisting of a supervisor (the chief of the Anesthesia Department); a pediatric anesthesiologist (an attending physician, working on the ward); a third-year resident (from the School of Pediatrics) with training in pediatric advanced life support, who changed every 8 months; and 2 nurses from the gastroenterology unit with training in pediatric basic life support.

After 3 months, in January 2000, all patients admitted to the pediatric, gastroenterology, and oncology wards who needed invasive procedures and had no contraindications for sedation underwent procedural sedation in the PSU. Continuous auditing of the new sedation protocol was commenced, including reports of the gastronterologist, the oncologist, and the nurses from the departments.

For the first 180 patients, a questionnaire about satisfaction with procedure protocol was administered to the patients and/or parents. Since the answers to the first 180 questionnaires were impressively homogeneous, the collection of data was stopped.

TRAINING OF PERSONNEL

The personnel received preliminary instructions about the pharmacologic features of the agents commonly used during sedation (especially propofol), and everybody was trained to recognize the complications associated with sedation and anesthesia. Each resident was trained as planned in the postgraduate school in pediatrics. The residents were trained in cardiopulmonary resuscitation, bag-valve-mask (BVM) ventilation, and use of resuscitation drugs. They spent a 4-week training period in the operating room (OR) and pediatric intensive care unit, with an active experience in patient intubation (BVM ventilation and tracheal intubation at least 20 times), and then spent 8 months in the gastroenterology unit dedicated to sedation activity and gastroenterology.

For the first month, all the procedures in the PSU were performed jointly by the resident and the pediatric anesthesiologist as part of the training. After the month of training with the pediatric anesthesiologist, the residents ultimately performed the procedures independently. Since sedation performed by residents is not a routine standard of care, the pediatric anesthesiologist was always informed about the starting of a procedure and was always in the ward (a few yards away on the same floor) as a further safeguard for all procedures attended by the resident.

SELECTION OF PATIENTS

From January 1, 2000, to December 31, 2002, procedural sedation was offered to all children admitted to the pediatric, gastroenterology, and oncology wards for invasive procedures (ie, colonoscopy, upper endoscopy, lumbar puncture, bone marrow aspiration, liver biopsy, arthrocentesis, muscle biopsy, skin biopsy, intestinal washout, and paracentesis). Children excluded were those with common contraindications to sedation6 (Table 1) and with American Society of Anesthesiologists (ASA) classifications III and IV (Table 2). The residents performed the patient history and physical examination.

Table Graphic Jump LocationTable 1. Common Contraindications to Sedation

Since the PSU was performing deep sedation/general anesthesia, anesthesia guidelines were chosen. In accordance with the ASA guidelines, clear fluids were not allowed for 3 hours; infant formula and nonhuman milk, for 6 hours; and solids, for 8 hours.7 An intravenous 20- to 22-gauge line (Insyte by Vialon; Becton Dickinson, Madrid, Spain) was inserted, usually on the back of the hand, after application of a eutectic cream mixture of local anesthetics (lidocaine and prilocaine in an emulsion base) (EMLA cream; AstraZeneca, Milan, Italy). When already present (mostly in children in the oncology ward), a central venous line was used. EMLA cream was applied also to the site of painful procedures (ie, bone marrow aspiration, lumbar puncture, and joint puncture) to decrease perception of pain and possibly the depth of sedation. Parents were encouraged to stay close until the child was asleep.

DEFINITION OF THE PROTOCOL

Intravenous atropine sulfate was administered (0.01 mg/kg before starting propofol infusion) as a premedication in all subjects to reduce the risk for laryngeal irritation due to salivary secretion (even if propofol does not cause hypersecretion) and the risk for bradycardia induced by pain reflexes (especially during colonoscopy).

Propofol was injected slowly, for at least 2 minutes, with an induction dose of 2 mg/kg in children 8 years or younger and 1 to 2 mg/kg in older children; the repeated dose was 0.5 to 1 mg/kg (or a continuous infusion at 6-9 mg/kg per hour when a long procedure was foreseen). Propofol was diluted with lidocaine hydrochloride, 1 mg for 10 mg of propofol for the first syringe in all children without a central line. The nurses prepared propofol with an aseptic technique just before each procedure, and the residents were aware of the risk for infection. A 20-mL syringe was used for children weighing more than 20 kg, a 10-mL syringe for those weighing more than 10 kg, and a 5-mL syringe for smaller patients to reduce the risk for overdose. During the procedures, a continuous infusion of pediatric glucosaline solution (Isolyte P) (for children 5 years or younger) or Ringer lactate (for children older than 5 years) was administered at the normal maintenance rate for weight and age.

All endoscopies and painful oncologic procedures were performed in the routine lateral position, which further provides better airway patency and drainage of secretions with less likelihood of stimulating laryngospasm.

For the first 2 years of the study, the PSU chose to not administer oxygen in children undergoing endoscopies unless required for desaturation or apnea. This choice was made to avoid the risk for undetected hypoventilation disguised by oxygen delivery and to make residents more aware of the risks for respiratory depression.1 After the second year, since a significant number of mild and short-lived episodes of hypoxemia was experienced, residents administered oxygen (6 L/min) by mask close to the face to anticipate hypoxemia.4 For children undergoing painful procedures, mostly those with cancer, a deeper level of sedation was initially foreseen, and supplemental oxygen during the procedure was given from the beginning of the study.

LEVEL OF SEDATION AND MONITORING

The sedation end point was generally deep sedation. Nevertheless, patients were allowed to drift back and forth along a continuum, ranging from moderate to deep sedation to general anesthesia, with the goal of a balance between the maximum of comfort and safety. General anesthesia was not the average sedation end point, but the residents were free to increase the depth of sedation as needed. Deep sedation was defined for a sedation limit as a sluggish response to a light glabella tap or a loud auditory stimulus. The level of general anesthesia was defined as any episode of unresponsiveness to touch or voice lasting between 2 controls (≤5 minutes). The maximum transiently acceptable depth of sedation was defined as general anesthesia for patients retaining only a reflex withdrawal to pain. During the procedures, the resident was in charge of constant monitoring of the patient (position of the head and neck, breathing, respiratory sounds, paradoxical respiratory movements, cyanosis, heart rate, monitoring of arterial oxygen saturation [SaO2], blood pressure measurement, and check for level of sedation every 5 minutes) with the help of one of the 2 nurses (also in charge of preparing the drugs and the suction and oxygen-delivering devices with appropriate masks). At the end of the procedure, at least 10 minutes of observation occurred, before the patients were transferred back to the ward, to check for any adverse events, since this period is known to be one of risk. Before patients were moved back to the ward, vital signs had to be normal, with SaO2 saturation within the reference range without oxygen administration and a level of sedation inferior to that of general anesthesia.

Once in their rooms, the patients were monitored by means of SaO2 by the nurses and the residents in the ward (all personnel provided by the Pediatric Basic Life Support Training) until fully awake. The pediatric anesthesiologist was readily available on the ward should an adverse event occur. All resuscitation equipment was present in the ward as well. The parents were actively involved in the observation of the children; they all received instructions about the correct position and the meaning of saturation and were encouraged to call in case of any doubt or problem.

Patients were discharged from the hospital after complete recovery, which was defined as the presence of vital variables within reference limits, full wakefulness, the ability to drink or eat, and the ability to walk normally. The decision as to whether the patient was ready for discharge was made by the resident in charge of the sedation. Time-based records were used for the entire sedation period, and notes in the patient's medical chart were recorded during further observation in the ward.

EQUIPMENT AND SETTING

The procedures were performed with a positive pressure oxygen delivery system (≤15 L/min) that could be used to provide continuous positive airway pressure by mask, 2 sets of functional suction apparatus with appropriate suction catheters, sphygmomanometer, and blood pressure cuffs (Dinamap Plus; Critikon Company, Tampa, Fla), pulse oximetry (512 Novametrix; Novametrix Medical Systems Inc, Wallingford, Conn), an emergency kit with resuscitation medications, and neuromuscular blocking agents.2,4,8 All the material required for intubation and a cardiac defibrillator were present as well. Routine capnography (Nellcare EC-4 NPB.75; Nellcor Puritan Bennett Inc, Pleasanton, Calif) with nostrils for oxygen delivery (Microstream Nellcare; Nellcare Puritan Bennett Inc) was introduced in the last 3 months.4 The same monitoring facilities and emergency kit were present in the ward.

The sedations occurred in the endoscopy room in the Gastroenterology Department; the PSU personnel move room to room only for painful procedures involving patients of the Oncology Department. The pediatric, gastroenterology, and oncology wards are all located on the same floor of the hospital, on the floor above the operating theater and intensive care unit of our third-level pediatric teaching hospital.

EMERGENCY PERSONNEL

The availability of the pediatric anesthesiologist with experienced advanced life support skills was almost immediate (in the ward), and the emergency team of the Anesthesia Department (1 physician and 1 nurse) was available on call as well. These personnel are available on call for all the needs of the hospital during the day and are able to carry out standard emergency procedure within a few minutes.

OUTCOMES AND DEFINITION OF COMPLICATIONS

We recorded the percentage of procedures successfully performed, the incidence and type of adverse events, and the number of calls for the pediatric anesthesiologist or the emergency team until discharge. Two different observers, the physician in charge of the sedation and a nurse from the Gastroenterology Department, monitored outcomes and complications. The risk for underreporting was further reduced by involving the pediatric gastroenterologist and the oncologist in the audit. A secondary outcome was the time of engagement of the OR spared by the PSU.

Minor desaturation was defined as any drop in SaO2 to less than 94%, with prompt recovery in spontaneous breathing with or without oxygen supplementation and without apnea. Major desaturation was defined as any drop in SaO2 or apnea needing a course of ventilation. Residents were trained to start BVM ventilation in case of apnea, defined as absence of breath for more than 10 seconds and whenever SaO2 dropped below 85% without prompt reversal with oxygen administration. Laryngospasm was defined clinically as evidence of stridor (with or without clinical signs of airway obstruction) and on a need-to-treat basis (BVM or continuous positive airway pressure ventilation). Blood pressure changes were defined as a drop in mean arterial pressure; hypotension was defined as 1 measurement below age-based criteria.

During the 36-month study period, the PSU performed 1059 procedures. In cases involving a single sedation for multiple procedures (ie, lumbar puncture plus bone marrow aspiration or upper endoscopy plus liver biopsy), only the longest procedure was recorded.

Data about the population involved in the study are shown in Table 3.

Procedures not included in this study were performed in the operating theater by an anesthesiologist (patients in ASA categories III and IV, operative procedures) or in the ward without sedation (older patients). The number and proportion of procedures performed in the ward for each year are shown in Table 4. No parents of children younger than 14 years refused sedation. Among patients older than 14 years, 206 (38.9%) of 530 preferred to undergo the procedure while awake. No parents requested that the procedure be performed in the OR.

Table Graphic Jump LocationTable 4. Procedural Sedation by the Study Year

The patients had several underlying medical conditions ranging from otherwise healthy children with suspected celiac disease (undergoing gastroscopy for duodenal biopsy) to gastrointestinal tract disorders (eg, gastritis, gastroesophageal reflux, inflammatory bowel disease, and liver diseases) to cancer (undergoing bone marrow aspiration, lumbar puncture, or bone biopsy) and to a few patients with juvenile rheumatoid arthritis (undergoing joint puncture).

Sedation was easily achieved in all procedures. All the procedures except 1 were performed successfully. The only failed procedure was an upper endoscopy in which a severe laryngospasm developed soon after the insertion of the instrument. The procedure was stopped and performed the next day in the OR uneventfully. No patients required intubation. The incidence of children transiently experiencing the level of sedation defined as general anesthesia at any time was 91% (reached in 963/1059 patients). Procedures lasted from a minimum of 5 minutes to a maximum of 47 minutes (upper endoscopy plus colonoscopy with multiple biopsies). The mean ± SD duration times were 10.0 ± 3.0 minutes for upper endoscopies, 24.0 ± 4.5 minutes for colonoscopies, and 8.0 ± 2.0 minutes for painful procedures.

The average propofol dose required for each procedure is shown in Table 5. Continuous infusion for long-lasting procedures was seldom used (12 patients only), since the residents usually chose to administer repeat small boluses of propofol when needed, on evidence of the patient's discomfort. All patients were aroused in a mean ± SD time of 14.0 ± 8.3 minutes after the end of the procedures (range, 1-42 minutes).

Table Graphic Jump LocationTable 5. Propofol Average Doses for the Different Procedures

All patients admitted as outpatient cases were discharged after an established 3-hour period of observation in the ward. Only 1 patient requested further observation (for repeated vomiting), and none returned for complications after discharge.

After calculating an average time of 30 minutes of engagement of the operating theatre for each procedure, we can estimate a saving of about 119 hours in 2000, 193 hours in 2001, and 231 hours in 2002.

COMPLICATIONS

The rate of respiratory complications for each year and kind of procedure is shown in Table 6 and Table 7. In most cases, the drop of SaO2 was mild and transient, with prompt recovery spontaneously or with oxygen supplementation. The incidence of more important desaturation was higher in patients before routine oxygen supplementation (SaO2 of <88% in 52 [12.0%] of 432 patients), less frequent in those with oxygen supplementation (SaO2 of <88% in 12 [1.9%] of 627 patients). The lowest SaO2 in patients before and after oxygen administration with the mask close to the face was 78% and 82%, respectively; with oxygen administration via the nostrils, the minimum SaO2 experienced was 91%.

Table Graphic Jump LocationTable 6. Distribution of Complications of Sedation in Endoscopies by Study Years
Table Graphic Jump LocationTable 7. Distribution of Complications of Sedation in Painful Procedures

Laryngospasm and major desaturation needing assisted ventilation occurred mostly in young children (Table 6 and Table 7). Three of 5 children needing assisted ventilation were younger than 1 year, and all 10 children with laryngospasm were younger than 4 years. All courses of ventilation for hypoventilation were managed immediately by the residents and lasted less than 40 seconds. Laryngospasm was treated with oxygen, BVM or continuous positive airway pressure, and suctioning of secretion, and by deepening the level of anesthesia in 2 cases. The BVM or continuous positive airway pressure for laryngospasm lasted a few minutes (range, 1-9 minutes). There was no need for muscle relaxant or intubation.

One major problem occurring in 13 children undergoing upper endoscopies was difficulty in inserting the instrument (Table 6). In these cases, after a short cycle of ventilation, a level of general anesthesia was reached and the gastroscopy tube was inserted with the help of a laryngoscope by the pediatric anesthesiologist. All of these patients maintained spontaneous breathing and the procedures were performed uneventfully.

The pediatric anesthesiologist of the PSU was called in every case presenting with laryngospasm and whenever laryngoscopy was needed to insert the endoscope. All of these occurrences were considered emergency calls (Table 6 and Table 7). The other calls for the emergency department staff were for an episode of prolonged laryngospasm (>5 minutes) after upper endoscopy and for bleeding from esophageal varices during upper endoscopy (unrelated to sedation). The prolonged laryngospasm was also treated empirically with inhaled epinephrine bitartrate (2 mg) and intravenous corticosteroids to reduce the hypothetical vocal cord edema due to trauma from the endoscope. The symptoms had almost completely resolved when the emergency team arrived. During the bleeding from esophageal varices, the endoscopist controlled the bleeding (by perilesional injection of epinephrine), and the pediatric anesthesiologist administered an infusion of saline, albumin, and blood to quickly stabilize the patient.

In 8 cases, a moderate drop in SaO2 (range, 88%-92%) was observed just after the end of the procedure. All of these patients maintained spontaneous breathing and supplemental oxygen was administered by the residents for a few minutes. During the additional period of observation in the ward, oxygen supplementation in spontaneous breathing was briefly necessary only for 5 children because of an SaO2 below 93%.

Pain along the intravenous line after propofol injection was the most frequent adverse effect. It was reported on injection in 460 (48.0%) of 958 procedures (excluding patients with central venous catheters), despite simultaneous lidocaine infusion.

A decrease in mean arterial blood pressure from baseline values occurred in 720 (68.0%) of 1059 cases, with a mean decrease of 16 mm Hg (range, 0 to −34 mm Hg). The maximum decreases in blood pressure were generally observed at 5 and 10 minutes after the beginning of the procedure. In all the cases, decrease in blood pressure was transient and not associated with abnormal perfusion or other clinically significant signs. Heart rate remained substantially stable, and no case of bradycardia was observed. According to age-defined criteria, 137 (12.9%) of 1059 patients showed low blood pressure (systolic or diastolic) at any time. No precise indications were established about treatment of hypotension, and residents were free to administer bolus fluids. This occurred in 32 (3.0%) of 1059 patients, mostly patients with cancer (29/32). Transient myoclonus was observed in 31 (2.9%) of 1059 patients.

One patient with Shwachman syndrome and abnormal electroencephalographic findings but no history of seizures underwent a bone marrow puncture and experienced a brief tonic-clonic seizure and opisthotonos a few seconds after the infusion of propofol. The episode lasted 10 seconds and spontaneously subsided.

One patient experienced generalized repeated seizures 3 hours after a lumbar puncture with infusion of methotrexate without concomitant corticosteroid infusion. The oncologist recognized the origin of the event in the antineoplastic drug, and the patient underwent further sedations with propofol without complications.

Three patients experienced repeated vomiting, and another 4 experienced an unpleasant awakening with agitation. No patient experienced hangover, ataxia, or other adverse effects.

SATISFACTION OF PATIENTS AND THEIR FAMILIES

The questionnaire was given to the first 180 patients and completed by 112 parents of young children and by 62 patients older than 12 years.

Satisfaction and a request for the same sedation in any eventual subsequent procedure were indicated in the questionnaire by 100% of parents of young children and by 95.8% of adolescents who responded to the questionnaire on their own.

Some of the parents of small children (8.1%) experienced a sensation of distress while watching their child lose consciousness. Fifteen percent of parents of younger children and 5% of adolescents expressed the desire for an oral premedication.

The critical issue addressed by this study concerns the use of propofol by nonanesthesiologists and non–intensive care unit personnel. In the real world, deep sedation is usually required to achieve anxiolysis and immobilization necessary for painful pediatric procedures,9 and the risk for oversedation is very high.5,10 The PSU defined oversedation as any episode of unresponsiveness to touch or voice lasting up to 5 minutes, and many would consider such sedation depth to be general anesthesia. As reported by Dial et al,10 our data confirm that transient oversedation is almost unavoidable whenever a high degree of immobilization is required. Nevertheless, the safety record of our series is good, and in the literature a similar level of complications is reported when propofol is compared with other sedatives of more widespread use such as midazolam hydrochloride and opioids.1113

Deep sedation has been compared with walking on a tightrope, and the primary causes of morbidity associated with sedation or analgesia are drug-induced respiratory depression and airway obstruction. In our experience, the absolute number of episodes of desaturation was quite high when the drug was used without concurrent administration of oxygen. Nevertheless, most of these episodes were mild, short-lived, and easily managed by trained nonanesthesiology personnel, with prompt recovery of spontaneous breathing. Moreover, the incidence of mild episodes of desaturation appeared to be partly avoidable by preventive oxygen administration. The incidence of episodes of desaturation requiring a short course of ventilation was very low, and the residents easily managed all these cases. According to the literature, the incidence and severity of desaturation appear to be related to selection of patients (inaccurate estimation of airway patency), infusion rate of the drug, ability to detect signs of hypoventilation, and degree of immobility required.10 Most of these variables can be managed with good training and by the use of experienced personnel.

From our preliminary data, the use of propofol in a non–intensive care unit setting with previously trained personnel in an appropriate environment and with concurrent oxygen administration appears to guarantee satisfactory sedation. Although our study series is too small to detect a difference in the rate of adverse events, rare during standard practice, it did not show important complications for colonoscopies and painful procedures. Furthermore, our preliminary data seem to indicate that trained personnel can recognize hypoventilation promptly and treat desaturation episodes successfully, confirming the advantages of the drug in terms of easy dose titration and quick recovery.1417

On the other hand, the safety profile of propofol sedation for upper endoscopy is not so good, and our experience could not prove its use to be absolutely safe in this setting. In some cases, it may be impossible to pass the endoscope without reaching a level of general anesthesia for laryngoscopy. The rate of laryngospasm, although quite low in the absolute, is nonetheless too high to be considered safe, and the occurrence of major desaturation in upper endoscopy, requiring assisted ventilation, is higher compared with colonoscopies and painful procedures. Moreover, most of the indications for gastroscopy could result in a delayed gastric emptying with an increased risk for inhalation. Therefore, it is not appropriate to perform upper endoscopy with propofol in a sedation unit with residents in attendance. On the contrary, as far as colonoscopies and painful procedures are concerned, the incidence of laryngospasm was extraordinarily low. Decrease in mean arterial pressure was always transient and not associated with abnormal perfusion or other clinically significant signs, as reported in the literature.2,8,12

The most frequent adverse effect was pain during propofol infusion, which actually distressed many patients. The incidence of pain might have been lower with a higher (but still safe) dose of lidocaine (2% rather than 1%).18 In this kind of experience, the constant availability of anesthesiology support remains mandatory.4

In this study, we made great efforts to develop high standards of safety, in terms of personnel training, to ensure the development of the skills required (eg, selection of patients, infusion rate velocity, ability to maintain airway patency, ability to recognize hypoventilation, and ventilation skills) and an environment with safety guarantees (eg, monitoring and treatment facilities and anesthesiology support). This experience offered the residents a unique opportunity to practice the use of sedative drugs and enhance their skills monitoring patients and providing life support, with an amazing professional gain. Nevertheless, residents exceeded the intended target of sedation at some time in more than 90% of cases. Therefore, the risk for oversedation appears almost a rule when sedation is performed by attending physicians and when the depth of sedation is titrated to the maximum comfort of the patient and a good degree of immobility.9,10

Before the start of this experience, most of the invasive procedures were performed in the OR with the support of anesthesiologists. Since anesthesiology resources were limited, not all procedures could be conveniently performed under sedation. Moreover, there was significant loss of time due to the difficulties in scheduling the OR because of emergencies and surgery activity.

The development of a PSU in the ward made it possible to significantly increase the number of procedures performed, along with possible savings of time for the Anesthesiology Department. The time spent by the Anesthesiology Department and by the pediatric anesthesiologist in training the residents must be taken into account in the cost-benefits ratio, despite the fact that the training in the Anesthesiology Department is part of the standard rotation of residents in our school of pediatrics.

The absolute number of procedures and the percentage of procedures performed with sedation have increased significantly since the study was commenced (Table 4). With less demand on the OR schedule, we were more readily able to accommodate those patients who definitely needed an anesthesiologist. Moreover, other patients have benefited from being able to plan more independently the timing of procedures because of the increased availability of an OR. The savings related to OR engagement are possibly overestimated, because some of these procedures would once have been performed without sedation and therefore would not have had an impact on the OR. Nevertheless, these patients chose to receive sedation when the possibility was offered without any limitation based on scheduling or OR engagement.

The responses to the questionnaires indicated significant convenience for patients and parents. The children do not leave the ward, but fall asleep and wake up with their parents nearby. Furthermore, they are no longer subjected to delays due to problems in the OR, and fasting times are more easily respected.

The use of propofol by pediatric residents with defined training and the availability of prompt anesthesiology resources did not result in important complications for colonoscopies and painful procedures. Furthermore, they allowed a significant increase in the number of procedures performed with sedation. Although far more data are needed to assess the safety of propofol outside an intensive care environment, we believe that further studies in this direction will be promising and worthwhile.

Corresponding author and reprints: Egidio Barbi, MD, Clinica Pediatrica, IRCCS Burlo Garofolo, University of Trieste, Via dell'Istria 65/1, 34100 Trieste, Italy (e-mail: ebarbi@libero.it).

Accepted for publication May 1, 2003.

We thank the nurses of the Gastroenterology Unit, Fulvia Balsemin, RN, Manuela Filaferro, RN, and Laura Spetti, RN, for their precious help and support.

What This Study Adds

The need to perform procedural sedation for children has increased in recent years, but anesthesiology resources are limited. Deep sedation is usually required to achieve anxiolysis and immobilization necessary for painful pediatric procedures. Propofol is an attractive option for procedural sedation in children, but the safety profile of this drug in a nonanesthesiology setting has not been defined. This study shows that trained nonanesthesiology personnel can safely use propofol in a defined setting with significant savings of anesthesiology resources.

Krauss  BGreen  SM Sedation and analgesia for procedures in children. N Engl J Med. 2000;342938- 945
PubMed Link to Article
Lowrie  LWeiss  AHLacombe  C The pediatric sedation unit: a mechanism for pediatric sedation. Pediatrics [serial online]. 1998;102E30Accessed January 5, 2003
PubMed
Green  SM Propofol for emergency department procedural sedation: not yet ready for prime time. Acad Emerg Med. 1999;6975- 978
PubMed Link to Article
American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists, Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002;961004- 1017
PubMed Link to Article
Pena  BMKrauss  B Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med. 1999;34483- 491
PubMed Link to Article
Sury  MRJHatch  DJDeeley  TDicks-Mireaux  CChong  WK Development of a nurse-led sedation service for paediatric magnetic resonance imaging. Lancet. 1999;3531667- 1671
PubMed Link to Article
Not Available, Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anaesthesiologists Task Force on Preoperative Fasting. Anesthesiology. 1999;90896- 905
PubMed Link to Article
Not Available, Guidelines for monitoring and management of paediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics. 1992;891110- 1115
PubMed
Maxwell  LGYaster  M The myth of conscious sedation [editorial]. Arch Pediatr Adolesc Med. 1996;150665- 666
PubMed Link to Article
Dial  SSilver  PBock  KSagy  M Pediatric sedation for procedures titrated to a desired degree of immobility results in unpredictable depth of sedation. Pediatr Emerg Care. 2001;17414- 420
PubMed Link to Article
Havel Jr  CJStrait  RTHennes  H A clinical trial of propofol vs midazolam for procedural sedation in a pediatric emergency department. Acad Emerg Med. 1999;6989- 997
PubMed Link to Article
Bauman  LAKish  IBaumann  RCPolitis  GD Pediatric sedation with analgesia. Am J Emerg Med. 1999;171- 3
PubMed Link to Article
Nadwindy  LASmith  LJJones  ABSeal  RF The use of propofol vs diazepam/meperidine for pediatric GI endoscopic procedures. Paper presented at 7th Annual Meeting of the North American Society of Pediatric Gastroenterology and Nutrition November 5-6, 1993 Chicago, IllAbstract 7
Hertzog  JHCampbell  JKDalton  HJHauser  GJ Propofol anesthesia for invasive procedures in ambulatory and hospitalized children: experience in the pediatric intensive care unit. Pediatrics [serial online]. 1999;103E30Accessed January 5, 2003
PubMed
Sasaki  SOkuvama  AIdeuchi  NMorimoto  YKemmotsu  O Propofol anesthesia for ambulatory surgery in adults. Masui. 2000;491161- 1164
PubMed
Hertzog  JHDalton  HJAnderson  BD  et al.  Prospective evaluation of propofol anesthesia in the pediatric intensive care unit for elective oncology procedures in ambulatory and hospitalized children. Pediatrics. 2000;106742- 747
PubMed Link to Article
Buck  ML Propofol use in children: weighting the benefit and risk. Pediatr Pharmacother. 2000;61- 6
Adachi  HInagaki  YHarada  T  et al.  Effects of concentration and dosage of lidocaine on preventing the pain on injection of propofol. Masui. 2002;51983- 987
PubMed

Figures

Tables

Table Graphic Jump LocationTable 1. Common Contraindications to Sedation
Table Graphic Jump LocationTable 4. Procedural Sedation by the Study Year
Table Graphic Jump LocationTable 5. Propofol Average Doses for the Different Procedures
Table Graphic Jump LocationTable 6. Distribution of Complications of Sedation in Endoscopies by Study Years
Table Graphic Jump LocationTable 7. Distribution of Complications of Sedation in Painful Procedures

References

Krauss  BGreen  SM Sedation and analgesia for procedures in children. N Engl J Med. 2000;342938- 945
PubMed Link to Article
Lowrie  LWeiss  AHLacombe  C The pediatric sedation unit: a mechanism for pediatric sedation. Pediatrics [serial online]. 1998;102E30Accessed January 5, 2003
PubMed
Green  SM Propofol for emergency department procedural sedation: not yet ready for prime time. Acad Emerg Med. 1999;6975- 978
PubMed Link to Article
American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists, Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002;961004- 1017
PubMed Link to Article
Pena  BMKrauss  B Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med. 1999;34483- 491
PubMed Link to Article
Sury  MRJHatch  DJDeeley  TDicks-Mireaux  CChong  WK Development of a nurse-led sedation service for paediatric magnetic resonance imaging. Lancet. 1999;3531667- 1671
PubMed Link to Article
Not Available, Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anaesthesiologists Task Force on Preoperative Fasting. Anesthesiology. 1999;90896- 905
PubMed Link to Article
Not Available, Guidelines for monitoring and management of paediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics. 1992;891110- 1115
PubMed
Maxwell  LGYaster  M The myth of conscious sedation [editorial]. Arch Pediatr Adolesc Med. 1996;150665- 666
PubMed Link to Article
Dial  SSilver  PBock  KSagy  M Pediatric sedation for procedures titrated to a desired degree of immobility results in unpredictable depth of sedation. Pediatr Emerg Care. 2001;17414- 420
PubMed Link to Article
Havel Jr  CJStrait  RTHennes  H A clinical trial of propofol vs midazolam for procedural sedation in a pediatric emergency department. Acad Emerg Med. 1999;6989- 997
PubMed Link to Article
Bauman  LAKish  IBaumann  RCPolitis  GD Pediatric sedation with analgesia. Am J Emerg Med. 1999;171- 3
PubMed Link to Article
Nadwindy  LASmith  LJJones  ABSeal  RF The use of propofol vs diazepam/meperidine for pediatric GI endoscopic procedures. Paper presented at 7th Annual Meeting of the North American Society of Pediatric Gastroenterology and Nutrition November 5-6, 1993 Chicago, IllAbstract 7
Hertzog  JHCampbell  JKDalton  HJHauser  GJ Propofol anesthesia for invasive procedures in ambulatory and hospitalized children: experience in the pediatric intensive care unit. Pediatrics [serial online]. 1999;103E30Accessed January 5, 2003
PubMed
Sasaki  SOkuvama  AIdeuchi  NMorimoto  YKemmotsu  O Propofol anesthesia for ambulatory surgery in adults. Masui. 2000;491161- 1164
PubMed
Hertzog  JHDalton  HJAnderson  BD  et al.  Prospective evaluation of propofol anesthesia in the pediatric intensive care unit for elective oncology procedures in ambulatory and hospitalized children. Pediatrics. 2000;106742- 747
PubMed Link to Article
Buck  ML Propofol use in children: weighting the benefit and risk. Pediatr Pharmacother. 2000;61- 6
Adachi  HInagaki  YHarada  T  et al.  Effects of concentration and dosage of lidocaine on preventing the pain on injection of propofol. Masui. 2002;51983- 987
PubMed

Correspondence

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 48

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles