Clinical Trial of Oral Midazolam in Pediatric Endoscopy | NCT00636428

Studies
Clinical Trial of Oral Midazolam in Pediatric Endoscopy

NCT00636428

Sponsor

Tabriz University

Status

Completed

Last Update Posted

Apr 11, 2008Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Endoscopy

Interventions

Midazolam

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Mar 7, 2008

First Submission Date that Met QC Criteria

Mar 13, 2008

First Posted Date

Mar 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2008

Last Update Posted Date

Apr 11, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Oral midazolam	Drug: Midazolam
2	Active Comparator	IV Midazolam	Drug: Midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
efficacy and safety of endoscopy in children with used midazolam

Secondary Outcomes

Measure	Description	Time Frame
The level of sedation
patient complications, ease of performing the procedure, time of preparation, time for recovery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mandana Rafeey, Dr	liver &Gastrointestinal Research center of tabriz medical university	Study Chair
Mandana Rafeey, Dr	tabriz medical university	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liver &Gastrointestinal Research center of tabriz medical university		Tabriz	East Azarbijan	51664	Iran

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided