Clinical Trial of Oral Midazolam in Pediatric Endoscopy

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00636428
First received: March 7, 2008
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Endoscopy
Drug: Midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Resource links provided by NLM:


Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • efficacy and safety of endoscopy in children with used midazolam [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The level of sedation [ Designated as safety issue: Yes ]
  • patient complications, ease of performing the procedure, time of preparation, time for recovery [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oral midazolam
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.
Other Name: Midazolam
Active Comparator: 2
IV Midazolam
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.
Other Name: Midazolam

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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636428

Locations
Iran, Islamic Republic of
Liver &Gastrointestinal Research center of tabriz medical university
Tabriz, East Azarbijan, Iran, Islamic Republic of, 51664
Sponsors and Collaborators
Tabriz University
Investigators
Study Chair: mandana Rafeey, Dr liver &Gastrointestinal Research center of tabriz medical university
Study Chair: Mandana Rafeey, Dr tabriz medical university
  More Information

No publications provided

Responsible Party: Alireza Javadzadeh, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00636428     History of Changes
Other Study ID Numbers: 85-24
Study First Received: March 7, 2008
Last Updated: April 8, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Tabriz University:
endoscopy
Midazolam
pediatric
sedation
comfort

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014