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

Shahid Beheshti University

Status and phase: Unknown; Phase 3

Conditions: Conscious Sedation

Treatments: Drug: Promethazine

Study type: Interventional

Funder types: Other

Identifiers

NCT01118884

171598

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 36 to 96 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 1 patient group

sedation

Experimental group

Description:

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.

Treatment:

Drug: Promethazine