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Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00636428
Enrollment
50
Registered
2008-03-14
Start date
2007-03-31
Completion date
2008-03-31
Last updated
2008-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy

Keywords

endoscopy, Midazolam, pediatric, sedation, comfort

Brief summary

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

Detailed 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.

Interventions

DRUGMidazolam

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.

Sponsors

Tabriz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
efficacy and safety of endoscopy in children with used midazolam

Secondary

MeasureTime frame
The level of sedation
patient complications, ease of performing the procedure, time of preparation, time for recovery

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026