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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118884
Recruitment Status : Unknown
Verified April 2010 by Shahid Beheshti University.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2010
Last Update Posted : May 7, 2010
Information provided by:
Shahid Beheshti University

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.

Condition or disease Intervention/treatment Phase
Conscious Sedation Drug: Promethazine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : June 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : May 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Behavior change [ Time Frame: 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.

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Ages Eligible for Study:   36 Months to 96 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Sedighe Mozafar, Shahid Beheshti University Identifier: NCT01118884     History of Changes
Other Study ID Numbers: 171598
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: April 2010

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
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Anesthetics, Local