NCT04153084

Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy

Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 126 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.

Conditions

• Digestive Illness

Interventions

Type	Name	Description
DRUG	Polyethylene Glycol 4000 with electrolytes	The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
DRUG	PEG-3350 with electrolytes	The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
DRUG	Sodium picosulfate	The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age: * From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h) * From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night. * From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night. * Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-12-15
• Completion: 2019-12-31
• First posted: 2019-11-06
• Last updated: 2019-11-08

Locations

8 sites across 1 country: Spain