Safety of a 1-Day Polyethylene Glycol 3350 Bowel Preparation for Colonoscopy in Children.

OBJECTIVES: Electrolyte-free polyethylene glycol powder (PEG-3350) has been widely used for colonoscopy preparation (prep); however, limited safety data on electrolyte changes exists with 1-day prep regimens. The primary aim of this study was to determine the proportion of patients with significant serum chemistry abnormalities before and at the time of colonoscopy. Secondary aims included evaluation of prep tolerance and bowel cleansing efficacy. METHODS: We performed a prospective descriptive observational study of pediatric patients scheduled for outpatient colonoscopy who received our standard 1-day, weight-based 4 g/kg PEG-3350 prep with a single stimulant laxative dose and had serum chemistry testing within 60 days before and at the time of colonoscopy. A standardized bowel cleanliness tool (Aronchick scale) was completed by the endoscopist. RESULTS: One hundred fifty-five patients had serum electrolytes data pre- and postprep. Comparison of each patient's chemistries demonstrated statistical equivalence with the 1 exception of blood urea nitrogen levels (P = 0.56). Hypokalemia was detected postprep in 37 subjects (24%), but none had a serum level <3.3 mmol/L, which was deemed to be of no clinical significance. Five patients were hypoglycemic post prep; 3 were 7 years or younger (P = 0.02). The colon cleanliness rating was excellent or good in 77% and suboptimal in 23% of patients. CONCLUSIONS: A 1-day, weight-based PEG-3350 bowel prep in children appears safe. Changes in electrolyte levels and renal function were not clinically significant. Children of 7 years or younger seem to be at a higher risk of hypoglycemia compared with older children.

Polyethylene glycol powder solution versus senna for bowel preparation for colonoscopy in children.

OBJECTIVES: Safety and effectiveness of large-volume polyethylene glycol-based solution (PEG-ES) have been documented, but the taste and volume can be barriers to successful colonoscopy preparation. Efficacy and safety of small-volume electrolyte-free (PEG-P) preparation (Miralax) for colonoscopy preparation have been rarely studied, although presently used at many pediatric centers. The primary objective of the present study was to determine whether PEG-P results in a more efficacious and safe colonoscopy preparation as compared with senna. METHODS: The study design was prospective, randomized, and single-blinded. Patients ages 6 to 21 years were randomized to a 2-day clean-out regimen of PEG-P at a dose of 1.5 g/kg divided twice per day for 2 days versus senna 15 mL daily (ages 6-12) or 30 mL daily (ages 12-21) for 2 days. Both preparations required 1 day of clear liquids whereas senna preparation required an additional day of full liquid diet. A blinded endoscopist graded the quality of preparation with a standardized cleanliness tool (Aronchick scale). Serum chemistry panels were obtained. Patients or parents rated symptoms and ease of preparation. The anticipated number of subjects was 166; however, the interim analysis demonstrated inferiority of senna preparation. RESULTS: Thirty patients were evaluated in the present study. Of the patients in the PEG-P arm, 88% (14/16) received an excellent/good score compared with 29% (4/14), with the senna preparation (P = 0.0022). Both preparations were well-tolerated by patient-graded ease of preparation. Demographics and laboratory values did not differ significantly across the 2 groups. No serious adverse events were noted. CONCLUSIONS: PEG-P is an effective colonoscopy preparation whereas senna preparation was insufficient. Both were well-tolerated and appear safe in a pediatric population.

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.