Procedural Sedation in Children Undergoing Diagnostic and Therapeutic Procedures Outside the Operating Room in a Tertiary Care Centre: A Clinical Audit

INTRODUCTION: Sedation and analgesia is frequently administered to pediatric patients for procedures done outside the operating room. It is poorly understood that procedures done outside the operating room require the same attention to anxiolysis, analgesia, sedation and safety guidelines as procedures performed in the operating room. To this end we require appropriate definitions, goals, guidelines, monitoring and adequately trained personnel. Nonpainful procedures like magnetic resonance imaging (MRI), computed tomography (CT scan), electroencephalography (EEG) and electromyography (EMG) require immobility but no analgesia. Procedures like radiotherapy also require an absolutely immobile patient. Painful procedures like bone marrow aspiration, lumbar puncture, repair of minor surgical wounds, and insertion of arterial and venous catheters, burns dressing changes, fracture reduction, endoscopy and bronchoscopy require deep sedation or general anesthesia. The fear of entering a closed space for imaging studies remains considerably high. This is especially true in young children and the mentally handicapped. The whole issue is compounded by parental anxiety, seperation from parents and pain or anticipation of pain during the procedure. Procedures like bronchoscopy, endoscopy and central line placement which were previously done in operating rooms (OR) are now being increasingly done outside the OR partly due to time constraints, partly in an effort to decrease cost and partly due to fear of the complications of sedation. Due to these factors, children are often subjected to sedation by unskilled personnel with no training in resuscitation. In other cases children who would have benefited by sedation are being denied sedation and are left with long term psychological scars. In an effort to identify areas of sedation and monitor sedation practices we decided to audit all children undergoing diagnostic or therapeutic procedures in our tertiary care institution, for a period of one month, after meeting the personnel of departments dealing with these children discussing the purpose of this audit and checking on equipment and personnel training available. AIMS AND OBJECTIVES: 1. To audit the existing practice of procedural sedation in children in our tertiary care centre. 2. To compare the existing practice with the international guidelines thereby analyzing the efficacy of the existing practice. 3. To recommend changes in the existing practice so as to improve patient safety during procedural sedation. MATERIALS AND METHODS: Phase I: sedation practices are not uniform across the hospital. Reports of morbidity led us to look at the problems in the existing practice and to identify the need for change. Defining criteria and standards: We looked at and accepted the JCAHO and ASA guidelines as the standard against which we would compare and or assess modes of sedation /analgesia in our centre. Phase II: Identification of areas where procedural sedation is given: the next step in carrying out the audit is the identification of areas where sedation and analgesia are practiced. We chose seven departments in the hospital who were sedating children on a regular basis for diagnostic and therapeutic procedures. These included departments of child health, pediatric surgery, hematology, neurology, otorhinolaryngology, radiology and gastroenterology. The anesthetists were involved directly in the MRI suite, CT scan area, sonology suite and in the endoscopy room. In the other areas, nonanesthesiologists were involved in sedating children for procedures. Phase III: Information and permission: Prior to starting the data collection, we contacted the departments we had identified in phase II and presented the need to do this audit, at their clinical meetings. This was done with a short power point presentation as well as the proforma, for their perusal and comments. Their input was co-opted into our next phase of “data collection”. Phase IV: Data collection: This phase was planned for a period of one month simultaneously in all the areas. Two separate data collection sheets were used. The first proforma helped document the structure of the sedating area. It collected general details about the sedation. 1. Facilities and equipment available in the area, 2. Personnel present during sedation and their training in resuscitation, 3. Sedation protocol followed, 4. Documentation, 5. Discharge criteria or protocol. These details were collected by the investigator with the permission of the concerned personnel The second proforma was individualized to each patient (process). This had the following details, 1. Patient information (name, age sex, hospital number, diagnosis and current medications), 2. Details of preprocedural evaluation (history and examination findings), 3. Drugs used on the patient, dosage route and time of administration, 4. Details of the monitoring don eon the patient, 5. Postprocedural complications if any, 6. The criteria met at discharge, These details were filled up in the sheet by the physician or surgeon doing the procedure. Phase V: Assessing performance (outcome) against standards. To compare the data collected with the international standards. Phase VI: Identification of the changes needed. After comparing the existing practice with the JCAHO and ASA guidelines, certain recommendations which would improve patient safety will be drafted. Phase VII: Feedback to the concerned departments. The data collected and the drafted recommendations were then presented to each of the seven departments as a power point presentation. STATISTICAL METHODS: The study is a clinical audit done for a period of one month (November 2005). We included all children who underwent procedures under sedation in the identified areas as our study group. We had a total of 252 cases in the study period. After data collection, descriptive analysis of the data was done to compute the frequency and percentage of occurrence of deficiencies and complications; a deficiency being the absence or nonavailabilty of a facility or requirement (appendix III & IV). As the total number of cases is less (n=252), it is very difficult to calculate the statistical significance, but it has got enormous clinical significance which will be dealt with in detail under “discussion”. CONCLUSION: Audit as defined by many authors implies a critical review of events. Clinical audit aims at detecting mismanagement and the “avoidability” of adverse outcomes of clinical management. In our audit, we detected varying degrees of mismanagement in each of the seven areas studied. The pitfalls both in terms of the “structure” and “process” of procedural sedation in children were pointed out to the concerned departments, with recommendations for changes in the existing policies so as to improve patient safety and outcome. Some of these recommendations are already being implemented as seen in the EEG lab which is now sedating children based on their weight. The use of largactil is also banned in the lab. Thus clinical audit can be rightly considered an action-oriented research, aimed at putting findings into operation in order to correct mismanagement and to improve norms with a focus on avoidability issues