This trial is active, not recruiting.

Condition conscious sedation
Treatment promethazine
Phase phase 3
Sponsor Shahid Beheshti University
Start date June 2009
End date April 2010
Trial size 20 participants
Trial identifier NCT01118884, 171598


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
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.
promethazine Phenergan
Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours

Primary Outcomes

Behavior change
time frame: during dental treatment which is 30 minutes after drug ingestion

Eligibility Criteria

Male or female participants from 36 months up to 96 months old.

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

Additional Information

Official title Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment
Principal investigator Sedighe Mozaffar
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Shahid Beheshti University.