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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Conscious Sedation

Intervention / Treatment
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* Drug: Promethazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 96 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sedation<br>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. | Drug: Promethazine<br>* Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours<br>* Other names: Romergan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, Nitrous oxide, Behaviour management