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

Phase 3

• Conditions: Conscious Sedation
• Interventions: Drug: Promethazine

• Registration Number: NCT01118884
• Lead Sponsor: Shahid Beheshti University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Status Verified: 2010-04
• Primary Completion: 2010-04
• Study First Submitted: 2010-04-26
• Study Completion: 2010-05
• Study First Submitted QC: 2010-05-06
• Last Update Submitted: 2010-05-06
• Study First Posted: 2010-05-07
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sedation	Promethazine	20 healthy uncooperative children aged 36-96 months were examined in a cross-over study design , each patient served as his/her own control. Each patient was assigned randomly to received 1 of 2 drug regimens for initial sedation session and the other regimen administered at second session which was one week later.

Primary Outcome Measures

Name	Time	Method
Behavior change	during dental treatment which is 30 minutes after drug ingestion	Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.

Trial Locations

Locations (1)

Dental school of Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of