Published online November 30, 2007
PEDIATRICS Vol. 120 No. 6 December 2007, pp. e1411-e1417 (doi:10.1542/peds.2007-0145)
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ARTICLE

Propofol Sedation: Intensivists' Experience With 7304 Cases in a Children's Hospital

Michael Vespasiano, MDa, Marsha Finkelstein, MSb and Stephen Kurachek, MDa

a Children's Respiratory and Critical Care Specialists
b Center for Care Innovation and Research, Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
OBJECTIVE. The objective of this study was to determine the safety profile of propofol as a deep-sedation agent in a primarily outpatient program consisting of pediatric critical care physicians and specifically trained nurses with oversight provided by anesthesiology. One hypothesis was investigated: adverse events and/or airway interventions are more likely to occur in children with an abnormal airway score.

METHODS. A 36-month dual-site prospective, observational, clinical study was conducted in a single center with interchangeable providers operating within the guidelines of a single sedation program. A total of 7304 propofol sedations for 4464 unique patients who ranged in age from 1 month to 21 years were studied; >97% of the children were >1 year of age.

RESULTS. The following adverse reactions were identified, and a descriptive statistical analysis of the data were performed: mild oxygen desaturation (85%–90%), 1.73%; serious oxygen desaturation (<85%), 2.9%; laryngospasm, 0.27%; regurgitation without aspiration, 0.05%; regurgitation with aspiration, 0.01%; bronchospasm, 0.15%; and hypotension, 31.4%. Interventions required included oral airway, 0.96%; nasal trumpet, 1.57%; rescue breaths for >1 minute, 0.37%; intubation, 0.03%; volume requirement of >40 mL/kg per hour, 0.11%; sedation-induced ward or PICU admission, 0.04%; cardiac arrest medications, 0%; and aborted sedation or procedure, 0%. We devised an airway score to identify at-risk patients. Patients with an abnormal airway score were significantly more likely to: have oxygen desaturation (13.1% vs 4.3%); require an oral airway (5.9% vs 0.8%); and require a nasal trumpet (13.9% vs 1.2%).

CONCLUSIONS. Propofol has an acceptable safety profile for deep sedation when used in the context of a program with critical care physicians, specifically trained nurses, and anesthesiology oversight. A preprocedure airway score can assist in identifying patients who may require airway interventions.

Key Words: propofol • pediatric sedation program • adverse events • airway score

Abbreviations: ED—emergency department • SN—sedation nurse • CSP—children's sedation program • CT—computed tomography • ETCO2—end-tidal carbon dioxide • ASA—American Society of Anesthesiologists • BP—blood pressure • NPO—nulla per os

Pediatric patients who receive diagnostic studies or limited invasive procedures often require sedation to prevent excessive motion and alleviate pain and anxiety. The increased demand for interventions that require sedation in the outpatient setting challenges an institution's resources to accommodate the safe and effective throughput of a large number of infants and children. A variety of sedation program models have emerged in which nonanesthesiologists provide sedation care as a result of the limitations of the operating room as a sedation venue as well as time constraints on anesthesiologists.

Propofol, a sedative-hypnotic agent introduced, studied, and now used extensively in the operating room for the induction and maintenance of anesthesia, has attractive pharmacologic properties as a deep-sedation agent.1–9 Its rapid onset, predictable level of sedation, and rapid recovery with minimal adverse effects account for the migration of propofol outside the operating room to a variety of sedation venues, including radiology, emergency department (ED), intensive care, and specific sedation units.10–16 Limited studies11,17–19 have assessed the effectiveness and safety of propofol as a deep-sedation agent when administered by nonanesthesiologists.

A single-center, dual-site, prospective study was performed to assess the safety profile of propofol in a sedation program using critical care physicians, nurses trained in pediatric sedation (SN), and anesthesiology oversight. We sought to identify important adverse events, unplanned interventions, and sedation failure within a large pediatric population. We also devised a children's sedation program (CSP) airway score, a method for classifying patients who may require airway interventions.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
For this single-center, dual-site, prospective cohort study, approval was obtained from the investigational review board of Children's Hospitals and Clinics of Minnesota. Informed consent was waived for this observational study. All patients who received deep sedation for diagnostic studies and/or therapeutic procedures through the CSP at Children's-Minneapolis or Children's-St Paul during the 36-month interval from November 2002 through December 2005 were enrolled in the study. Children were excluded from the study when no attempt at sedation was made because of acute illness or a condition that required the specialized skills of an anesthesiologist. The most active sedation venues included radiology (MRI, computed tomography [CT], and nuclear medicine), short-stay unit (primarily hematology/ oncology patients for lumbar puncture, intrathecal chemotherapy, and bone marrow aspirates), and special diagnostic unit (electroencephalogram, evoked potentials, and hearing tests). The sedation team was occasionally summoned to the ED or PICU for sedation assistance. All sedation venues are equipped with cardiorespiratory monitoring, pulse oximetry, oxygen, suctioning, a pediatric cardiopulmonary resuscitation cart, and "Dr Blue" (cardiopulmonary arrest signal) activation switch. End-tidal carbon dioxide (ETCO2) monitoring per nasal cannula is performed routinely for all patients undergoing MRI and as needed when risk factors are present.

Sedation Program
The program is structured in adherence to guidelines and standards developed by the American Academy of Pediatrics,20,21 the American Society of Anesthesiologists (ASA),22 and the Joint Commission on Accreditation of Healthcare Organizations.23 The program is governed by a multidisciplinary committee with representation from critical care, nursing, anesthesiology, oncology, cardiology, and emergency medicine. People who administer propofol sedation all are credentialed in accordance with the sedation policy of Children's Hospitals and Clinics of Minnesota.

Sedation Process
The SN performs a presedation assessment, which is reviewed with the intensivist. Informed consent for sedation is obtained before proceeding. The intensivist and the SN are physically present throughout the sedation intervention. All patients who are administered propofol receive supplemental oxygen and are monitored for pulse oximetry, cardiac rhythm, blood pressure (BP), and in longer cases ETCO2 and temperature. Sedation level is monitored according to a standardized score and recorded every 3 minutes through the peak period of sedation until recovery. The score is based on a previously devised 5-point sedation scale: (1) agitated; (2) alert; (3) calm; (4) drowsy; and (5) asleep, nonrousable, and does not respond to minor stimulation.24 Intermittent bolus doses of propofol are used for shorter interventions (eg, oncology procedures, CT scans, central lines), whereas a continuous infusion of propofol after an initial bolus is used for longer interventions (eg, MRI). All propofol dosing including changes in continuous infusion rate are double checked by the intensivist and the SN. Propofol dosing is rarely <2 mg/kg. Continuous infusion in most cases is initiated at 150 µg/kg per minute and titrated as required. Supplemental boluses of 1 to 2 mg/kg are commonly used to maintain the patient's lack of movement through the procedure. Propofol infusion pain is managed by the use of lidocaine at the discretion of the intensivist.

Cardiorespiratory function, pulse oximetry, and vital signs are continually monitored until wakeup occurs. Transfer to the general ward or discharge from the hospital occurs on meeting strict standardized criteria. Discharge criteria include a return to baseline vital signs, oxygen saturation, and motor activity. The patient must have intact airway reflexes, age/developmentally appropriate interaction, and tolerance of enteral intake.

Airway Score
The critical care physicians developed an airway score to augment ASA classification during telephone triage. Airway class 1 patients do not have historical features that seem to place them at increased risk for airway compromise during sedation. In contrast, airway class 2 patients have historical elements or features that might place them at risk for airway compromise during sedation. Using a formatted questionnaire telephone interview (Fig 1) and subsequent presedation assessment, the following characteristics result in the assignment of airway class 2: current stridor, snoring, obstructive sleep apnea, morbid obesity, craniofacial malformation, symptomatic asthma or heart disease, gastroesophageal reflux disease, swallowing dysfunction, or previous airway problems with sedation or anesthesia. All airway class 2 patients as well as ASA 3 patients identified by telephone triage are reviewed by the critical care physician for possible referral to anesthesiology for sedation care.


Figure 1
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  		FIGURE 1 Twenty-four clinical indicators that focus on airway, cardiorespiratory, and global events or interventions were followed.

 
Outcome Assessment
A quality audit tool (Fig 1) was designed to assess the safety of propofol use within the context of the CSP and is completed by the critical care physician and reviewed and cosigned by the SN after checking for accuracy. The tool consists of demographic information and 24 clinical indicators with a focus on airway, respiratory, and cardiovascular events and/or interventions. Practice standards of supplementing each sedation patient with oxygen and using a pulse oximeter are emphasized. The lowest saturation observed during the sedation intervention is recorded, and the degree of desaturation is defined as mild (85% to <90%) or serious (<85%). BPs are obtained by an automated pneumatic system with an appropriate size cuff. The lowest systolic BP during the sedation intervention is recorded. Hypotension is defined as a drop of systolic BP of ≥25 mmHg from baseline. If the baseline systolic BP seems elevated as a result of anxiety or stress, then "normal" systolic BP for age is substituted for the baseline recording as defined at ≥50th percentile for age (Table 1). 25 The intensivist completes the quality tool, and after reviewing the data with the SN, both cosign the form. The sedation provider form is also reviewed and signed by the intensivist and the SN at the end of the sedated procedure. Chart reviews were triggered by the following clinical indicators: laryngospasm, intubation, bronchospasm, arrhythmias, regurgitation, adverse drug reaction, and sedation-induced admission.


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  		TABLE 1 Normal Systolic BP According to Age

 
The analysis included completed quality audits for patients who received propofol for deep sedation from November 2002 through December 2005. Simple descriptive statistics defined the incidence of adverse clinical events, the requirement for intervention(s), and negative global outcomes. Two-sided {chi}2 analysis was used to determine the following: the relationship between hypotension and patients who received an MRI, the relationship between hypotension and age in patients undergoing MRI, and airway class as a predictor of respiratory events. On the basis of a previous report26 that showed patient age to be associated with the development of hypotension (mean age: 61 months), we defined older patients as >5 years. P < .05 was considered statistically significant. All statistical tests were performed with SPSS 11.5 (SPSS Inc, Chicago, IL).


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 CONCLUSIONS
 REFERENCES
 
During the 36-month study period, 7689 audits were available for review; 385 (5%) audits were excluded because they were incomplete. The excluded forms displayed no pattern with regard to age or outcome measures and did not significantly effect measures of incidence of clinical indicators.

The age distribution of the patients and location of sedation are described in Table 2. More than 97% of the patients were older than 1 year, and almost two thirds of sedations took place in the radiology department. The short-stay unit is the primary site for sedations directed at hematology/oncology patients who require lumbar punctures, intrathecal chemotherapy, bone marrow aspirates, and bone marrow biopsies. Electroencephalograms and hearing tests account for almost all sedation interventions in the special diagnostic unit.


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  		TABLE 2 Patient Characteristics

 
The incidence of clinical indicators is shown in Table 3. Airway/respiratory events such as laryngospasm, bronchospasm, regurgitation, and aspiration occurred infrequently, whereas desaturation, albeit brief and rapidly rectified in most cases, occurred in almost 5% (n = 338) of the patients. Approximately 2.6% (n = 192) of the patients required some form of airway/respiratory intervention (eg, oral airway, nasal trumpet, rescue breaths, intubation) but only 2 of these patients were intubated, both by the intensivist. Both cases were infants who had a history of prematurity and chronic lung disease and were undergoing an MRI procedure. They each developed apnea after an initial dose of propofol. No patients were hypotensive at baseline. Hypotensive events were commonplace, occurring in at least 31% (n = 2299) of the patients. These events were usually self-limited, and urgent (rapid volume infusion) and/or high-volume (fluid > 40 mL/kg per hour) fluid infusions were distinctly uncommon. Hypotension was significantly more common during sedation interventions for MRI (42.5% [1329 of 3128]) than those performed for non-MRI indications (23.2% [970 of 4176]; P < .001, {chi}2). For patients not undergoing MRI, hypotension was statistically more common in children who were older than 5 years (Table 4).


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  		TABLE 3 Clinical Indicators

 

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  		TABLE 4 Hypotension According to MRI Procedure and Age

 
More than 3% (n = 237) of the patients were assigned an airway class 2 designation and statistically had a higher incidence of desaturation and/or a requirement for an oral airway or nasal trumpet (Table 5). Twenty-five (81%) of 31 patients who experienced desaturations were categorized as serious at <85%.


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  		TABLE 5 Relationship Between Airway Class and Respiratory Events

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
CONCLUSIONS
 REFERENCES
 
This single-center, prospective study is the largest investigation of its kind to assess the safety profile of propofol used as a deep-sedation agent outside the operating room. We found that propofol sedation delivered by intensivists and nurses with advanced training under the auspices of a multidisciplinary sedation committee was effective and safe in an outpatient setting. Similar pediatric studies* that assessed the efficacy and/or safety of propofol captured 1059 sedation interventions compared with the 7304 cases reviewed in this study, 4464 of which were unique patients. For evaluation of the outcome of an agent such as propofol in the context of a specific sedation program, a large-volume study such as ours is important given that the occurrence of adverse events can be infrequent. Other studies in which factors that can complicate outcomes exist have limited comparability to this investigation. For example, several groups15,16,28 that assessed the efficacy of propofol in an ED setting enrolled a high number of ASA 2 to 3 patients or patients with a variable nulla per os (NPO) status. Another observational study29 involving pediatric ED physicians who provided sedation for diagnostic imaging did not include assessment of the depth of sedation as part of patient monitoring. Procedural sedation is only 1 dimension of an ED's activities, whereas the structure and oversight of providing this service is the primary focus of a sedation program.

In accordance with Joint Commission for Accreditation for Hospitals and Other Related Institutions guidelines, our sedation program is governed by a sedation committee that capitalizes on the expertise and experience of our institution's anesthesiologists. Policies and procedures are shared between the sedation program and anesthesiology practice.

The outcomes of this study compare favorably to other studies. Localized pain on administration was a common identified adverse effect. When peripheral intravenous catheters were in place, 1% lidocaine was commonly administered, although not on a consistent basis. The most common adverse effect of propofol is dosage-dependent hypotension as a result of direct smooth muscle vasodilation, blunted sympathetic activity, and reduced tachycardia as a result of diminished baroreceptor response.8,29 More than 30% of the children in this study had hypotension, an experience similar to other investigators.12,26,30 Hypotension was more common in patients who underwent MRI studies. These sedation interventions tended to be longer in duration and as a consequence required higher cumulative propofol dosing. Reed et al31 commented on the high degree of patient variability in propofol dosing to reach a target sedation level, and this was the case in our study. Children who were older than 5 years and received non-MRI sedation interventions also seemed more prone to hypotension. This may be attributable to higher propofol dosing that is required to overcome the baseline level of anxiety that older children experience. It is also our impression that the older child tends to be NPO for a period longer compared with the infant or toddler, who often receives clear liquids within the framework of our NPO guidelines. Propofol-induced hypotension seems to be transient and of little physiologic relevance in the relatively healthy child who remains well perfused with peripheral warmth and excellent capillary refill during a sedation intervention. Our greatest concern regarding hypotension is the additional insult that it might impart to the unusual child who experiences severe bronchospasm, anaphylaxis, or a cardiac dysrhythmia, complications that did not occur during this relatively large study.

In the dosages required for deep sedation, propofol can result in respiratory instability. The initial intervention is typically airway manipulation (eg, repositioning of the head), which often alleviates the problem. In this study, hypopnea and/or apnea that resulted in bag-valve-mask ventilation occurred in only 0.37% (n = 27) of the patients. Oxygen desaturation, however, occurred in almost 5% (n = 338), and airway obstruction that required an oral airway or nasal trumpet occurred in 2% (n = 76) of cases. The incidence of alveolar hypoventilation on the basis of apnea, hypopnea, or upper airway obstruction is likely higher than recorded because ETCO2 was not monitored in all patients and not systematically evaluated as part of this study. Oxygen desaturation is a late sign of alveolar hypoventilation, particularly in sedation patients who receive oxygen supplementation.32 Soto et al32 and Yldzdaçs et al33 reported on the difficulty in identifying apnea and hypoventilation by clinical examination and/or pulse oximetry and emphasized the attributes of ETCO2 monitoring as the first defense against hypoventilation. We reserve ETCO2 monitoring for patients who undergo lengthy (>10–15 minutes) diagnostic procedures.

Our hypothesis that an airway score that is generated from a formatted interview questionnaire that is performed by a nurse, in conjunction with subsequent assessment by a critical care physician, can assist in identifying patients who require airway interventions was true. The airway score was initially developed to emphasize to all members of the program the importance of identifying patients with a potentially complicated airway before arrival and securing for these individuals anesthesiology referral if necessary. Almost 240 patients were classified as airway type 2 patients, and they had 3, 6, and 12 times the incidence of desaturation, oral airway, and nasal airway placement, respectively. Unfortunately, in this study, we did not track patients who were referred to anesthesiology, but our impression is that most patients' requirement for anesthesiology services were attributed to potential airway complications that were recognized before the patients' arrival at the hospital. By embedding a high sensitivity to airway problems in the prehospital phase of our sedation process, we have minimized late anesthesiology referrals (after patient arrival), improved our communication regarding risk with parents/guardians, and proceeded with sedation interventions of class 2 patients with heightened caution.

This study had a number of notable limitations. Data elements in the quality audit tool were limited, compromising the scope of the project in favor of the simple practicality of physicians' collecting prospective data while they work. For example, more information on anesthesiology referrals would be instructive. Partitioning our clinical outcomes against propofol dosing and or sedation time might also be revealing. Because not all patients received ETCO2 monitoring during the study period, we did not specifically assess the incidence of hypoventilation as defined by capnography. ETCO2 monitoring is most commonly used during lengthy procedures and during CT and MRI scanning, when the intensivist's ability to monitor respiratory status directly is restricted. The combined incidence of desaturation and airway interventions is a poor surrogate for the presence of actual hypopnea/apnea. Finally, propofol safety is not equivalent to sedation success. Repeat sequencing during MRI that extends sedation time and limits patient throughput can erode the efficiency of a sedation schedule. Other determinants of success, such as better characterization of the postintervention period including time to discharge and patient/parent satisfaction, were not evaluated.


   CONCLUSIONS
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
REFERENCES
 
This prospective study of propofol safety within the context of a sedation program performed by critical care physicians and SNs under the auspices of a multidisciplinary committee with valued anesthesiology input is the largest investigation of its kind. Hypotension was commonplace but not problematic. It carries the potential as an additive hazard for the rare child who experiences a major complication such as anaphylaxis or severe bronchospasm. Respiratory events were common, particularly desaturation, but more study is required to determine the actual incidence of alveolar hypoventilation masked by supplemental oxygen therapy in the setting of a sedation program. Our simple airway score derived from a formatted questionnaire seems to be predictive of respiratory events and interventions but requires more refinement to be of greater clinical value. An airway score seems to be helpful in presedation triage, and more work is required to determine the incidence of, reasons for, and outcomes of anesthesiology referrals. Actively seeking potential airway complications before they occur, however, is a powerful educational concept that may benefit practitioners of a sedation program. In summary, propofol seems to be a safe deep-sedating agent in the context of a comprehensive sedation program.


   ACKNOWLEDGMENTS
 
We thank Megan V. Thygeson, scientific and technical writer at Children's Hospitals and Clinics of Minnesota, for assistance in the preparation of this article.


   FOOTNOTES
 
Accepted May 17, 2007.

Address correspondence to Michael Vespasiano, MD, Children's Respiratory and Critical Care Specialists, 2545 Chicago Ave S, Suite 617, Minneapolis, MN 55403. E-mail: mike.vespasiano{at}childrensmn.org

* Refs 11, 12, 15, 16, 18, 19, 26, and 27. Back

The authors have indicated they have no financial relationships relevant to this article to disclose.


   REFERENCES
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 

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PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics

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