Conscious SedationPhase 3NCT01118884
Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children
A Phase 3 study testing Promethazine in people with Conscious Sedation, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 96 monthsHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Promethazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 96 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Tonsil hypertrophy
- History of allergies
- Drooling or nocturnal snoring
Trial locations and contacts
1 site in 1 country.
Iran1 site
Dental school of Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province, 19839
About this study
Official title: Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment
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.
Read the 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.
- Conditions
- Conscious Sedation
- Being tested
- Promethazine
- Keywords
- Midazolam, Nitrous oxide, Behaviour management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PromethazineDrug
Also called Phenergan, Prothiazine, Promethegan, Romergan
Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Promethazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior change
Behavior evaluation was based on a scale proposed by Houpt et al. which establishes the following scores : sleep, movement, crying , overall behavior.
Measured: during dental treatment which is 30 minutes after drug ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startJun 2009
- Primary completionApr 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Investigators
- Sedighe Mozaffar, Principal investigator, Postgraduate student of Shahid Beheshti Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118884
- Sponsor's protocol ID
- 171598
- Status last verified
- Apr 2010
- First submitted
- 26 Apr 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedative Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide/Oxygen on Behavior Management of Uncooperative Children Receiving Dental Treatment
- ClinicalTrials.gov ID
- NCT01118884
- Acronym / sponsor ID
- 171598
- Conditions
- Conscious Sedation
- Keywords
- Midazolam, Nitrous oxide, Behaviour management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sedation | Experimental | Drug: Promethazine20 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. |
Who may qualify
- Ages
- 36 to 96 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Tonsil hypertrophy
- History of allergies
- Drooling or nocturnal snoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PromethazineAlso: Phenergan, Prothiazine, Promethegan, RomerganSyrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours | Drug | sedation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sedighe Mozaffar principal investigator
Postgraduate student of Shahid Beheshti Medicine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Promethazine in people with Conscious Sedation, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior change (time frame: during dental treatment which is 30 minutes after drug ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.