MedDataX Logo

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

NCT ID: NCT00636428

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endoscopy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endoscopy Midazolam pediatric sedation comfort

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Oral midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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.

2

IV Midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tabriz University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tabriz University of Medical Sciences

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

mandana Rafeey, Dr

Role: STUDY_CHAIR

liver &Gastrointestinal Research center of tabriz medical university

Mandana Rafeey, Dr

Role: STUDY_CHAIR

tabriz medical university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Liver &Gastrointestinal Research center of tabriz medical university

Tabriz, East Azarbijan, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

85-24

Identifier Type: -

Identifier Source: org_study_id