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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
Sponsor:
Information provided by:
Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT01118884
First received: April 26, 2010
Last updated: May 6, 2010
Last verified: April 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   36 Months to 96 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118884

Locations
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
Investigators
Principal Investigator: Sedighe Mozaffar Postgraduate student of Shahid Beheshti Medicine University
  More Information

No publications provided

Responsible Party: Sedighe Mozafar, Shahid Beheshti University
ClinicalTrials.gov 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:
Midazolam
Nitrous oxide
Behaviour management

Additional relevant MeSH terms:
Promethazine
Diphenhydramine
Midazolam
Nitrous Oxide
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on June 18, 2013