MedDataX Logo

Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients

NCT ID: NCT04608734

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2016-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Buccal midazolam

Group Type EXPERIMENTAL

Buccal midazolam

Intervention Type DRUG

The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.

Intranasal midazolam

Group Type ACTIVE_COMPARATOR

Intranasal midazolam

Intervention Type DRUG

Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buccal midazolam

The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.

Intervention Type DRUG

Intranasal midazolam

Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Negative and definitely negative behavior according Frankl's scale.
* ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
* Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.

Exclusion Criteria

* Children with multiple carious lesions who require treatment under general anesthesia.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yousr N Mowafy, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Nadia A Wahba, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Tamer M Ghoneim, PhD

Role: STUDY_CHAIR

Faculty of Medicine, Alexandria University, Egypt

Ghada M Mahmoud, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, University of Modern Sciences and Arts, Egypt.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Chopra R, Marwaha M. Assessment of buccal aerosolized midazolam for pediatric conscious sedation. J Investig Clin Dent. 2015 Feb;6(1):40-4. doi: 10.1111/jicd.12062. Epub 2013 Dec 20.

Reference Type BACKGROUND
PMID: 24357534 (View on PubMed)

al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.

Reference Type BACKGROUND
PMID: 11309871 (View on PubMed)

Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. No abstract available.

Reference Type BACKGROUND
PMID: 8247896 (View on PubMed)

Kupietzky A, Holan G, Shapira J. Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. Pediatr Dent. 1996 Jan-Feb;18(1):32-4.

Reference Type BACKGROUND
PMID: 8668567 (View on PubMed)

Primosch RE, Guelmann M. Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent. 2005 Sep-Oct;27(5):401-8.

Reference Type BACKGROUND
PMID: 16435641 (View on PubMed)

Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6. No abstract available.

Reference Type BACKGROUND
PMID: 3857559 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Buccal vs intranasal midazolam

Identifier Type: -

Identifier Source: org_study_id