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Clinical Trial of Oral Midazolam in Pediatric Endoscopy

T

Tabriz University

Status and phase

Completed
Phase 4

Conditions

Endoscopy

Treatments

Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

1
Active Comparator group
Description:
Oral midazolam
Treatment:
Drug: Midazolam
2
Active Comparator group
Description:
IV Midazolam
Treatment:
Drug: Midazolam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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