Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Endoscopy Clinical Trial

Official title:

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636428
• Other study ID #: 85-24
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2008
• Last updated: April 8, 2008
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Tabriz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.

Description:

Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation.

Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• All of patients scheduled for endoscopy participated in the study.

Exclusion Criteria:

Exclusion criteria were as follows:

• Children younger than 3 years;

• Children with significant neurological disability;

• Children with a history of allergies to benzodiazepines, or to their components;

• Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation;

• Children with respiratory distress

• Age under 1 mo and bigger than 17y

• History of erythromycin used in 4 week ago

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Endoscopy

Intervention

Drug:
• Midazolam
oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Liver &Gastrointestinal Research center of tabriz medical university	Tabriz	East Azarbijan

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy and safety of endoscopy in children with used midazolam			Yes
Secondary	The level of sedation			Yes
Secondary	patient complications, ease of performing the procedure, time of preparation, time for recovery			Yes