NCT00636428

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

March 7, 2008

Last Update Submit

April 8, 2008

Conditions

Endoscopy

Keywords

endoscopyMidazolampediatricsedationcomfort

Outcome Measures

Primary Outcomes (1)

  • efficacy and safety of endoscopy in children with used midazolam

Secondary Outcomes (2)

  • The level of sedation

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

Study Arms (2)

1

ACTIVE COMPARATOR

Oral midazolam

Drug: Midazolam

2

ACTIVE COMPARATOR

IV Midazolam

Drug: Midazolam

Interventions

MidazolamDRUG

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.

12

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver &Gastrointestinal Research center of tabriz medical university

Tabriz, East Azarbijan, 51664, Iran

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • mandana Rafeey, Dr

    liver &Gastrointestinal Research center of tabriz medical university

    STUDY CHAIR

  • Mandana Rafeey, Dr

    tabriz medical university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

IR(1)