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Adverse Cardiovascular and Respiratory Events during Sedation of Pediatric Patients for Imaging Examinations¹

¹ From the Departments of Radiology (P.A.S., P.E.B., P.J.F., L.C., K.P.M.), Biostatistics (D.Z.), and Anesthesia (K.P.M.), Children's Hospital, 300 Longwood Ave, Boston, MA 02115; and Department of Anesthesia, Brigham and Women's Hospital, Boston, Mass (E.M.). Received August 31, 2004; revision requested October 26; revision received January 12, 2005; accepted February 1. Address correspondence to K.P.M. (e-mail: keira.mason{at}tch.harvard.edu).

	ABSTRACT

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PURPOSE: To retrospectively identify factors associated with an increased risk of adverse cardiovascular or respiratory events during sedation of pediatric patients for imaging examinations.

MATERIALS AND METHODS: This HIPAA-compliant study was institutional review board approved; the requirement for informed consent was waived. All sedation information—including patient demographics, medications (doses and routes of administration), time required to sedate and before discharge, American Society of Anesthesiologists physical status classification, adverse events, and failed sedations—was maintained in a computerized database. A review of the data on all patients sedated between 1997 and 2003 for magnetic resonance imaging, computed tomography, and interventional radiology revealed associated adverse respiratory events in 70 patients. Adverse respiratory event was defined as oxygen desaturation of at least 5%, pulmonary aspiration, and need for airway resuscitation. Adverse cardiovascular events were defined as cardiac arrest and hemodynamic changes requiring medical therapy. Adverse events were compared between sedation regimens—which included fentanyl, chloral hydrate, pentobarbital, and midazolam hydrochloride—by using the Fisher exact test. Multiple logistic regression analysis was applied to identify potential predictors of adverse events.

RESULTS: Among 16 467 sedations performed, 70 (0.4%) were associated with adverse respiratory events: 58 cases of oxygen desaturation, two pulmonary aspirations, 10 cases of airway resuscitation, and no cardiovascular events. Nearly 30% (n = 20) of the 70 patients who had an adverse event had a history of serious respiratory illness. Logistic regression analysis revealed that neither patient age, weight, or sex nor type of imaging procedure was associated with an increased risk of an adverse event. Use of a single sedation agent was associated with lower adverse event risk than was use of multiple agents (P < .001).

CONCLUSION: Consideration should be given to using single agents, avoiding the use of multidrug sedation regimens, and recognizing that a history of pulmonary disease could be associated with an increased risk of adverse respiratory events despite a currently stable respiratory state.

© RSNA, 2005

	INTRODUCTION

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Neonates and infants who undergo magnetic resonance (MR) imaging and computed tomography (CT) often require sedation to minimize motion artifacts. Patients who undergo interventional radiologic procedures usually require both sedation and analgesia to tolerate the procedure and facilitate optimal operating conditions. In 2003, our radiology department staff (at Children's Hospital, Boston, Mass) performed a total of 147 000 imaging examinations, at which 3443 patients required nurse-facilitated sedation and 1278 required anesthesia. With such a large sedation program, it is important to have a computerized database to track the medications administered, patient demographics, and adverse events. With this sedation database, we perform quality assurance, review existing protocols, and test new protocols. The creation and implementation of a computerized sedation database in 1997 has enabled our radiology sedation committee to regularly review our sedation practices and institute new protocols that have improved patient outcomes.

All sedation medications are administered by using a specific protocol, and all protocols are approved by both the radiology department sedation committee and the hospital sedation committee. Any deviation from the established sedation protocol for a unique situation or a particular patient or scenario must be approved on a case-by-case basis by an anesthesiologist before it is implemented.

Historically, chloral hydrate (Major Pharmaceutical, Rosemont, Ill) has been the drug of choice for the sedation of infants younger than 1 year (1–4). Rates of successful sedation with this medication range from 85% to 98% (5,6). Adverse events associated with chloral hydrate include oxygen desaturation, nausea, vomiting, hyperactivity, respiratory depression, and failed sedation (7). Until 1999, our radiology sedation protocol for infants younger than 1 year was limited to chloral hydrate administration. To lower rates of failed sedation, shorten times to discharge, and reduce the number and severity of adverse events, the radiology sedation committee investigated oral pentobarbital as an alternative for sedation. The results of a pilot study at our institution showed that oral pentobarbital flavored with cherry syrup was more palatable and as effective as chloral hydrate (8).

Follow-up studies have revealed that although oral chloral hydrate and pentobarbital are equally effective, oral pentobarbital is associated with fewer adverse events (9). On the basis of these findings, our radiology sedation committee and hospital sedation task force approved the use of an oral pentobarbital protocol for infants younger than 1 year, and since 1999, oral pentobarbital has been used in place of chloral hydrate as the primary sedative for infants undergoing MR imaging and CT examinations.

At our institution, children older than 1 year are sedated primarily with intravenous (IV) pentobarbital (Abbott Laboratories, North Chicago, Ill). In the event that this sedation is unsuccessful, fentanyl (Sublimaze; Janssen, Titusville, NJ) and subsequently midazolam hydrochloride (Versed; Hoffman-La Roche, Nutley, NJ) may be added to the regimen after consultation with an anesthesiologist. Rarely, an older child may not need full sedation and we administer IV fentanyl and/or midazolam hydrochloride to induce anxiolysis, analgesia, or a minimal degree of sedation. Other than the replacement of oral chloral hydrate with oral pentobarbital, our sedation protocol for radiologic procedures has remained unchanged since 1997. We did, however, perform a pilot study to evaluate the outcome of administering IV midazolam hydrochloride before administering IV pentobarbital. Administering midazolam hydrochloride before pentobarbital did not change the rate of sedation failures or adverse events (10). On the basis of these results, the original sedation protocol was left unchanged and preadministration of midazolam hydrochloride was not incorporated into the sedation protocol.

The purpose of our current study was to retrospectively identify the factors associated with an increased risk of adverse cardiovascular or respiratory events during sedation of pediatric patients for imaging examinations.

	MATERIALS AND METHODS

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Our Health Insurance Portability and Accountability Act–compliant study was approved by the institutional review board of Children's Hospital (Boston, Mass), and the requirement for informed consent was waived. In December 1993, a radiology sedation committee responsible for developing sedation guidelines for the radiology department, monitoring staff credentialing, and ensuring quality assurance was established. The radiology nursing staff collects and records specific information related to every sedation procedure. A single designated staff member (P.J.F.) transcribes this information into a computerized database (FileMakerPro, version 2.1; Claris, Cupertino, Calif). This database contains information on patient demographics (age and sex); the medical diagnosis rendered; the time, date, and type of the imaging examination performed; the patient's fasting duration; the medications administered; the routes of administration and doses (in milligrams per kilogram of body weight) of the sedatives given; the patient's American Society of Anesthesiologists physical status classification (11) at the time of sedation; the numbers and details of adverse and paradoxical events; the times required to sedate and to determine the postprocedural sedation score (Table 1); the time before discharge; and the numbers and details of failed sedations.

Sedation Protocols
All sedatives are administered by radiology nurses who are credentialed to administer sedatives by following strict guidelines and protocols established by the radiology sedation committee at our institution. All radiology nurses and supervising physicians must be credentialed to administer sedatives in the department of radiology. The established requirements for this credentialing include training in annual basic life support, training in biannual pediatric advanced life support, and passing an annual written sedation examination. The radiology nurses have extensive training in pediatric nursing, which usually includes pediatric intensive care, neonatal intensive care, and/or pediatric emergency room responsibilities.

Before sedatives are administered, all pediatric sedation candidates are screened by a radiology nurse for determination of whether the child has any medical conditions that would make him or her unsuitable to receive nurse-administered sedatives. Specifically, our sedation policies and guidelines include a radiology sedation committee–established list of medical conditions that are contraindications to the sedation of children (Fig 1) (9). Our sedation policies and guidelines include and expound on those recommended by the American Academy of Pediatrics (11,12).

View larger version (60K): [in this window] [in a new window] [Download PPT slide]   Figure 1. Medical conditions that contraindicate sedation performed by a nurse.

Sedation Techniques and Follow-up
All sedations are performed according to standards of the Joint Commission on Accreditation of Healthcare Organizations, the American Academy of Pediatrics, and the American Society of Anesthesiologists (11–13). Children younger than 12 months may be sedated with oral or IV medications. Before 1999, all oral-medication sedations were induced with chloral hydrate at our institution. After 1999, oral pentobarbital replaced chloral hydrate in our sedation protocol. The oral sedation protocols are as follows: Chloral hydrate syrup (100 mg/mL) was administered in doses of 20–50 mg/kg, up to a maximum dose of 2000 mg. Repeat doses of chloral hydrate could be administered every 30 minutes up to a maximum dose of 100 mg/kg. Pentobarbital (50 mg/mL) is prepared in a cherry syrup (Humco Cherry Syrup; Humco, Texarkana, Tex) and diluted to a 3:1 ratio. The initial dose is a standard 4 mg/kg dose that can be supplemented in aliquots of 2 mg/kg every 30 minutes up to a maximum dose of 8 mg/kg. When diluted, the volume of pentobarbital usually fits into a 3-mL syringe. Oral medications are administered directly into the mouth with a syringe while a parent holds the child.

Children older than 1 year receive IV sedatives only. This sedation protocol begins with IV pentobarbital administered at 2–6 mg/kg. Patients who are undergoing barbiturate therapy may receive up to 9 mg/kg. If the child does not become adequately sedated, the second line of therapy consists of 1–3 µg/kg fentanyl. In the event that the pentobarbital and fentanyl fail to keep the child adequately sedated for successful completion of the imaging examination, then midazolam hydrochloride (0.05 mg/kg IV or 0.5–0.75 mg/kg orally) may be added after direct consultation with the ordering radiologist and an anesthesiologist.

Children are monitored continuously after sedation. Their oxygen saturation, respiratory rate, and heart rate are recorded every 5 minutes during the procedure and every 15 minutes during recovery. Patients are discharged from the recovery area when they meet the modified discharge criteria of Aldrete and Kroulik (14). Patients must receive a score of 9 or 10 on the postsedation system scale to meet the discharge criteria (Table 1). At discharge, the patient or parent(s) receives an information sheet with instructions on the patient's care after sedation and a list of appropriate telephone numbers to contact if there are questions and concerns. Any complications that occur during or following the sedation (in the recovery room or at 24-hour telephone follow-up) are recorded. To ensure consistent identification and documentation of all events, the radiology sedation committee has established strict definitions for each adverse event. All adverse events are recorded in the computerized sedation database.

Definitions
The definitions associated with the adverse events recorded in the database are as follows (15):

Failed sedation.—Inadequate sedation of a patient after he or she has received the maximum allowable dosage of the sedative(s) per the sedation protocol or inability to complete the planned procedure secondary to unacceptable motion artifact.

Paradoxical reaction.—Sustained irritability or combativeness of a patient that occurs after sedative administration and lasts for more than 30 minutes.

Prolonged sedation.—Inability of a patient to meet discharge criteria 3 hours after sedative administration or to return to baseline mental and behavioral status within 24 hours after sedative administration.

Abnormal oxygen saturation.—Sustained decrease in oxygen saturation of 5% or greater from the baseline level for more than 1 minute, despite face-mask delivery of 6 L of oxygen per minute, head repositioning, suctioning, and physical stimulation.

Need for resuscitation.—Decreases in respiratory rate and oxygen saturation that require resuscitative efforts, including positive pressure ventilation, cardiopulmonary resuscitation, and/or the use of medications that reverse the sedation.

Cardiovascular complication.—Sustained (>5 minutes), greater than 20% decrease in mean arterial pressure with or without a decrease in heart rate below the lower limit of the normal range for the patient's age.

Unplanned admission.—Unexpected admission of a patient to the hospital overnight as a result of an adverse event directly related to the sedation.

Gastrointestinal side effect.—Vomiting, aspiration, or diarrhea occurring within 24 hours after sedative administration.

Allergic reaction.—Unexplained rash or allergic symptoms that develop within 24 hours after sedative administration.

Time to sedation.—Time in minutes from the initial administration of a sedative to the achievement of adequate sedation.

Time to discharge.—Time in minutes from the initial administration of a sedative to the time at which the patient meets the criteria for discharge from the recovery room.

Record Review
The computerized database was reviewed to compare the outcome variables among all children in whom sedation was induced from May 1997 to December 2003. The medical records of all patients (n = 70) who experienced adverse respiratory events, as identified from the database, were reviewed independently by two physicians (K.P.M., P.E.B.), a nurse (L.C.), and a nurse practitioner (P.A.S.) who were on the radiology sedation committee. To establish agreement on the occurrence and type(s) of adverse event(s), each of these individuals reviewed the medical records of each patient who had had a sedation-related adverse event. The nurse practitioner (P.A.S.), an anesthesiologist (K.P.M.), and the nurse (L.C.) then reviewed these medical records to determine whether each patient had a substantial history of respiratory disease. The respiratory diseases identified included asthma, bronchiolitis, pneumonia, congenital cystic adenomatoid malformation, bronchopulmonary dysplasia, interstitial lung disease, laryngotracheomalacia, respiratory syncytial virus, pleural effusion, acute respiratory distress syndrome, and cystic fibrosis.

Adverse respiratory event was defined as an abnormal oxygen saturation below 95%, pulmonary aspiration, and the need for airway resuscitation. In addition, individual patient records were examined for documentations of preexisting conditions, type(s) of sedating medication(s), sedative doses received, type(s) of radiologic procedure(s) performed (ie, MR imaging, CT, nuclear medicine, or interventional radiology), and verbal and written anesthesia consultations.

Statistical Analyses
A database chart review was completed, and 70 patients were identified as having sedation-related respiratory complications. No patients had cardiovascular complications, which were defined as hypotension, hypertension, arrhythmias, and/or cardiac arrest.

Rates of adverse events were compared between sedation groups by using the Fisher exact test (16). The normal approximation was used to determine 95% confidence intervals for adverse event rates (17). Multiple logistic regression modeling was applied to identify when patient age, weight, or sex; type of imaging procedure; and/or use of single- versus multiple-agent sedation regimens was a predictor of an adverse event. A backward selection procedure was applied, and the likelihood ratio test was used to assess the significance of the variables, with the odds ratio calculated as a measure of risk for the significant independent predictors (18). Two-tailed P values of less than .05 were considered to indicate a significant difference, with no adjustment for multiple testing. Data analyses were conducted by using the SPSS, version 12.0, software package (SPSS, Chicago, Ill).

	RESULTS

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A total of 16 467 sedations were performed in 13 408 pediatric patients (7553 male, 5855 female). The mean age and weight of the patients were 4.8 years ± 4.6 (standard deviation) and 20.1 kg ± 16.8, respectively. Of all the sedations, 69% involved MR imaging. American Society of Anesthesiologists status classifications of 1–5 were recorded; however, 95% of the sedations were performed in patients with classifications of 1 and 2. Patient demographics and imaging procedure characteristics are presented in Table 2.

View larger version (25K): [in this window] [in a new window] [Download PPT slide]   Figure 2. Histogram illustrates adverse respiratory event rates associated with nine sedation regimens. The highest adverse event rates were observed when multiple agents were used for pediatric sedation. The combination of IV pentobarbital (Pent) plus IV fentanyl (Fent) was associated with the highest adverse event rate (1.8). Across all regimens, a total of 16 467 sedations were performed and 70 (0.4%) adverse events occurred. CH PO/PR = oral or rectal chloral hydrate.

	DISCUSSION

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Data in the literature suggest that rates of sedation-related adverse events (3.8% with conscious sedation, 9.2% with deep sedation) may be reduced by applying the guidelines established by the American Academy of Pediatrics and the American Society of Anesthesiologists (11,13). Our adverse event rate was significantly lower than most of those reported in the literature (19,20). We believe that the reason for our sedation success rate was multifactorial—that is, a combination of the close supervision by the radiology sedation committee, the use of a reliable sedation database, the commitment to safety of the anesthesia department, and the expertise and experience of the radiologists and nurses. Most of our radiology nurses have extensive experience in the intensive care unit or emergency department care of pediatric patients. Nursing expertise is a critical component of a safe sedation program.

Having sedatives administered by personnel who are experienced in pediatric sedation and certified in pediatric advanced life support ensures safe and effective IV sedation in children (21,22). In addition, nonanesthesiologists who administer sedatives should be fully trained in the physiology of sedation and in the pharmacology of sedatives and analgesics (20,23,24). Pediatric resuscitation equipment (as recommended by the American Academy of Pediatrics) must be immediately available, and continuous pulse oximetry and clinical monitoring should be performed during sedation. The medical record of each patient who had had an adverse event was reviewed for a history of respiratory disease.

All statistical comparisons performed in this study were two tailed and involved the use of an value of .05; none of the comparisons were adjusted for multiple testing. This was a potential study limitation. In general, a P value indicates the risk of a false-positive error, which in this study referred to the probability of rejecting the null hypothesis and concluding that adverse event rates differed between certain sedation agents or of "overidentifying" variables that may have been associated with adverse events of failed sedations. However, because we wanted to be careful to identify any potentially important differences in adverse event rates, we chose not to adjust the P value. We acknowledge that this increased the likelihood that a reported difference may have been due to chance.

Thorough presedation review and screening guidelines are critical to maximizing the likelihoods of safe and successful outcomes for patients (13). In patient screenings performed before sedations, the childrens' cases must be assessed not only for current active medical issues but also for chronic conditions, such as asthma, that could compromise the patient during sedation.

Our study results show that the review of the medical history should be focused specifically on respiratory illnesses, which could increase the patient's risk of having an adverse respiratory event during sedation—even when the health status is stable and the respiratory illness is inactive. At our institution, there is a core group of radiology nurses and anesthesiologists who are dedicated to screening children prior to sedation. This consistent screening process has enabled us to perform sedations in patients who are in optimal condition to be sedated. With careful monitoring, adherence to carefully designed and safety-proved protocols, and strict adherence to recovery room guidelines and discharge criteria, we hope to maximize patient safety and successful outcomes.

Our investigation is important because, to our knowledge, it was the first study performed to search for a relationship between the method of sedation or the patient's medical history and an adverse cardiovascular or respiratory outcome. Our study results demonstrated that the sedation technique is critical to the outcome. Adherence to single-medication regimens, with the elimination of chloral hydrate altogether, is associated with the lowest rate of adverse events. Administration of multiple sedatives increases the risk of complications. Specifically, pentobarbital, midazolam hydrochloride, and fentanyl, each when administered alone, are associated with a low incidence of adverse events, but the incidence increases when these agents are combined with other sedatives. A medical history of serious respiratory disease could increase the risk of an adverse respiratory event, despite a currently stable state. On the basis of our findings, consideration should be given to using single sedative agents and avoiding the use of multidrug sedation regimens.

	ACKNOWLEDGMENTS

 
The authors acknowledge the assistance of Carol Vey for her administrative and technical expertise and assistance.

	FOOTNOTES

 

Abbreviations: IV = intravenous

Authors stated no financial relationship to disclose.

Author contributions: Guarantors of integrity of entire study, L.C., K.P.M.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; approval of final version of submitted manuscript, all authors; literature research, P.A.S., E.M., D.Z., L.C., K.P.M.; clinical studies, P.A.S., P.E.B., L.C., K.P.M.; statistical analysis, P.A.S., D.Z., P.E.B., P.J.F., L.C., K.P.M.; and manuscript editing, all authors

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This Article Abstract Figures Only Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Sanborn, P. A. Articles by Mason, K. P. Search for Related Content PubMed PubMed Citation Articles by Sanborn, P. A. Articles by Mason, K. P.