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Completed

NCT Number: NCT00636428

Clinical Trial of Oral Midazolam in Pediatric Endoscopy

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

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Key information

Conditions

Endoscopy

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liver &Gastrointestinal Research center of tabriz medical university

Tabriz, East Azarbijan, 51664, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

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.

Primary outcomes

  1. efficacy and safety of endoscopy in children with used midazolam

Secondary outcomes

  1. The level of sedation

  2. patient complications, ease of performing the procedure, time of preparation, time for recovery

Sponsors and collaborators

Lead sponsor

Tabriz University

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Apr 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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