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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608734
• Other study ID #: Buccal vs intranasal midazolam
• Status: Completed
• Phase: Phase 2
• Start date: June 10, 2015
• Est. completion date: June 25, 2016

Study information

• Verified date: October 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 25, 2016
• Est. primary completion date: June 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of drug administration	Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.	during the sedation procedure
Primary	Sleep score	This will be assessed using modified Houpt scale for behavior rating: Awake, alert.; Drowsy, disoriented.; Intermittently asleep.; Sound asleep.	after 5 minutes
Primary	Crying score	This will be assessed using modified Houpt scale for behavior rating: Hysterical, demands attention.; Continuous, making treatment difficult.; Intermittent, mild, does not interfere with treatment.; No crying present.	after 5 minutes
Primary	Head/oral resistance score	This will be assessed using modified Houpt scale for behavior rating: Turns head, refuses to open mouth.; Mouth closing, must request to open.; Chocking, gagging, spitting.; No head/oral resistance present.	after 5 minutes
Primary	Overall behavior	This will be assessed using modified Houpt scale for behavior rating: Aborted, no treatment performed.; Very poor, treatment interrupted, partial treatment completed.; Fair, difficult, all treatment completed.; Good, some limited crying or movement.; Excellent, no crying or movement.	immediately after completion of the dental treatment procedures