Safety of intravenous midazolam and fentanyl for pediatric GI endoscopy: prospective study of 1578 endoscopies.

BACKGROUND: Data on safety of intravenous sedation in pediatric GI endoscopy are sparse.

OBJECTIVE: To evaluate safety of intravenous sedation for GI endoscopy.

DESIGN/SETTING: Single-center prospective series of outpatient GI endoscopies performed from February 2003 to February 2004 at The Children's Hospital of Philadelphia. The recorded information included demographic, medication, and adverse event data.

PATIENTS: A total of 1226 patients were studied.

MAIN OUTCOME MEASUREMENTS: Description of adverse events relating to intravenous sedation.

RESULTS: A total of 2635 endoscopies were performed, of which 1717 were outpatient procedures with the patient under intravenous sedation. Sedation data were available on 1578 procedures (92%, M/F 674/552): 758 esophagogastroduodenoscopies (EGD) alone, 116 colonoscopies (COL) alone, and 352 combined EGD and COL. The median dose of fentanyl was 2.77 microg/kg (SD 0.97, range 0-6.73), and of midazolam was 0.11 mg/kg (SD 0.06, range 0-0.39). The mean recovery time was 118 minutes (SD 47.3, range 31-375). Ten patients (0.8%) failed intravenous sedation. Serious adverse events (apnea) were noted in 2 patients (0.2%). Mild or moderate adverse events included desaturation below 92% for less than 20 seconds (100 patients, 9%), vomiting (64 patients, 5%), agitation (15 patients, 1%), desaturation below 92% for greater than 20 seconds (12 patients, 0.7%), and rash (8 patients, 0.7%). No cardiopulmonary resuscitation or sedation reversal was necessary. No patients required hospitalization. Patients younger than 6 years were more likely to develop respiratory adverse event (P < .01).

CONCLUSIONS: Intravenous sedation with midazolam and fentanyl is safe for pediatric GI endoscopy. Serious adverse events are rare and no patient required hospitalization.