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

NCT04608734 | Completed Phase 2

• 1 other identifier: Buccal vs intranasal midazolam
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (5)

• 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

• Sleep score

  This will be assessed using modified Houpt scale for behavior rating: 1. Awake, alert. 2. Drowsy, disoriented. 3. Intermittently asleep. 4. Sound asleep.

  after 5 minutes

• Crying score

  This will be assessed using modified Houpt scale for behavior rating: 1. Hysterical, demands attention. 2. Continuous, making treatment difficult. 3. Intermittent, mild, does not interfere with treatment. 4. No crying present.

  after 5 minutes

• Head/oral resistance score

  This will be assessed using modified Houpt scale for behavior rating: 1. Turns head, refuses to open mouth. 2. Mouth closing, must request to open. 3. Chocking, gagging, spitting. 4. No head/oral resistance present.

  after 5 minutes

• Overall behavior

  This will be assessed using modified Houpt scale for behavior rating: 1. Aborted, no treatment performed. 2. Very poor, treatment interrupted, partial treatment completed. 3. Fair, difficult, all treatment completed. 4. Good, some limited crying or movement. 5. Excellent, no crying or movement.

  immediately after completion of the dental treatment procedures

Study Arms (2)

Buccal midazolam

EXPERIMENTAL

Drug: Buccal midazolam

Intranasal midazolam

ACTIVE COMPARATOR

Drug: Intranasal midazolam

Interventions

Buccal midazolam 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.

Buccal midazolam

Intranasal midazolam 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.

Intranasal midazolam

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with multiple carious lesions who require treatment under general anesthesia.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (6)

• 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.

  PMID: 24357534 BACKGROUND

• 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.

  PMID: 11309871 BACKGROUND

• 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.

  PMID: 8247896 BACKGROUND

• 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.

  PMID: 8668567 BACKGROUND

• 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.

  PMID: 16435641 BACKGROUND

• 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.

  PMID: 3857559 BACKGROUND

Study Officials

• Yousr N Mowafy, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Nadia A Wahba, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Tamer M Ghoneim, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

• Ghada M Mahmoud, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: October 29, 2020
• Study Start: June 10, 2015
• Primary Completion: June 13, 2016
• Study Completion: June 25, 2016
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

EG (1)