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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Shahid Beheshti University.
Recruitment status was  Active, not recruiting
Information provided by:
Shahid Beheshti University Identifier:
First received: April 26, 2010
Last updated: May 6, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Conscious Sedation
Drug: Promethazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • Behavior change [ Time Frame: during dental treatment which is 30 minutes after drug ingestion ] [ Designated as safety issue: Yes ]
    Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sedation
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
Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours
Other Names:
  • Phenergan
  • Prothiazine
  • Promethegan
  • Romergan

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.


Ages Eligible for Study:   36 Months to 96 Months   (Child)
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT01118884

Iran, Islamic Republic of
Dental school of Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of, 19839
Sponsors and Collaborators
Shahid Beheshti University
Principal Investigator: Sedighe Mozaffar Postgraduate student of Shahid Beheshti Medicine University
  More Information

Responsible Party: Sedighe Mozafar, Shahid Beheshti University Identifier: NCT01118884     History of Changes
Other Study ID Numbers: 171598 
Study First Received: April 26, 2010
Last Updated: May 6, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti University:
Nitrous oxide
Behaviour management

Additional relevant MeSH terms:
Nitrous Oxide
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents processed this record on October 28, 2016