NCT01118884

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
Last Updated

May 7, 2010

Status Verified

April 1, 2010

Enrollment Period

10 months

First QC Date

April 26, 2010

Last Update Submit

May 6, 2010

Conditions

Conscious Sedation

Keywords

MidazolamNitrous oxideBehaviour management

Outcome Measures

Primary Outcomes (1)

  • Behavior change

    Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.

    during dental treatment which is 30 minutes after drug ingestion

Study Arms (1)

sedation

EXPERIMENTAL

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

Interventions

PromethazineDRUG

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

Also known as: Phenergan, Prothiazine, Promethegan, Romergan
sedation

Eligibility Criteria

Age36 Months - 96 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Tonsil hypertrophy
  • History of allergies
  • Drooling or nocturnal snoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental school of Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, 19839, Iran

Location

MeSH Terms

Interventions

PromethazineDiphenhydramine

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthylaminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Sedighe Mozaffar

    Postgraduate student of Shahid Beheshti Medicine University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2010

First Posted

May 7, 2010

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

May 7, 2010

Record last verified: 2010-04

Locations

IR(1)