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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01118884

Enrollment

Registered

2010-05-07

Start date

2009-06-30

Completion date

2010-05-31

Last updated

2010-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

Keywords

Midazolam, Nitrous oxide, Behaviour management

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.

Interventions

DRUGPromethazine

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

36 Months to 96 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026