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.


METHODS
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.


METHODS
A total of 1226 patients were studied.


METHODS
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.
Mamula
Petar
P
Division of GI and Nutrition, The Children's Hospital of Philadelphia, Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA.
Markowitz
Jonathan E
JE
Neiswender
Kristin
K
Zimmerman
Ann
A
Wood
Stephanie
S
Garofolo
Michael
M
Nieberle
Megan
M
Trautwein
Andria
A
Lombardi
Susan
S
Sargent-Harkins
Lynn
L
Lachewitz
Greta
G
Farace
Lisa
L
Morgan
Verita
V
Puma
Anita
A
Cook-Sather
Scott D
SD
Liacouras
Chris A
CA
D000293:Adolescent; D000328:Adult; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D007223:Infant; D007275:Injections, Intravenous; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D016896:Treatment Outcome
D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008874:Midazolam; D005283:Fentanyl