Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children

Conscious Sedation Clinical Trial

Official title:

Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01118884
• Other study ID #: 171598
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 26, 2010
• Last updated: May 6, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2010
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of sedation using orally administered midazolam and promethazine with nitrous oxide/oxygen in uncooperative children receiving dental treatments.

Description:

The effectiveness of oral midazolam in pediatric dentistry is controversial. Usefulness of midazolam alone is limited to short-duration procedures, and we are needed to identify safe oral conscious regiments which permit longer duration procedures in dental treatments especially in Pediatric dentistry.

Promethazine is a long-acting (4-12 hr) anti-histaminic, H1 antagonist drug which acts as a central nervous system depressant and showing itself to be a weak anxiolytic drug.

The hypothesis to be tested is whether promethazine would improve the patients behavior during dental procedures without affecting vital signs, thus enabling longer periods of moderate or conscious sedation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 96 Months

Eligibility

Inclusion Criteria:

• Healthy patients who are in ASA class 1 group

• Age of the patients must be between 36-96 months

• Uncooperative children who are in groups 1 or 2 according to Frankel's classification

Exclusion Criteria:

• Tonsil hypertrophy

• History of allergies

• Drooling or nocturnal snoring

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Promethazine
Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental school of Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior change	Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.	during dental treatment which is 30 minutes after drug ingestion	Yes