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

NCT ID: NCT01118884

Last Updated: 2010-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Conscious Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

sedation

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.

Group Type: EXPERIMENTAL

Promethazine

Intervention Type: DRUG

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

Interventions

Promethazine

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

Intervention Type: DRUG

Other Intervention Names

Phenergan; Prothiazine; Promethegan; Romergan

Eligibility Criteria

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

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 96 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University

OTHER

Sponsor Role: lead

Responsible Party

Shahid Beheshti University

Principal Investigators

Sedighe Mozaffar

Role: PRINCIPAL_INVESTIGATOR

Postgraduate student of Shahid Beheshti Medicine University

Locations

Dental school of Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

171598

Identifier Type: -

Identifier Source: org_study_id