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

Information source: Shahid Beheshti University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Conscious Sedation

Intervention: Promethazine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Shahid Beheshti University

Official(s) and/or principal investigator(s):
Sedighe Mozaffar, Principal Investigator, Affiliation: Postgraduate student of Shahid Beheshti Medicine University


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Primary outcome: Behavior change

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.


Minimum age: 36 Months. Maximum age: 96 Months. Gender(s): Both.


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

Locations and Contacts

Dental school of Shahid Beheshti University of Medical Sciences, Tehran 19839, Iran, Islamic Republic of
Additional Information

Starting date: June 2009
Last updated: May 6, 2010

Page last updated: August 23, 2015

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