Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

NCT02679781 | Completed Results

• 1 other identifier: 0678-15-HMO-CTIL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Compliant With Oral or Nasal Midazolam Administration

  the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).

  the compliance in taking the medication will be assessed at the time of administration and recorded immediately.

Secondary Outcomes (1)

• Behavior During Dental Treatment

  the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.

Study Arms (2)

oral sedation

ACTIVE COMPARATOR

administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Drug: oral midazolam

nasal sedation

ACTIVE COMPARATOR

administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Drug: nasal midazolam

Interventions

oral midazolam DRUG

administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Also known as: oral dormicum

oral sedation

nasal midazolam DRUG

administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Also known as: nasal dormicum

nasal sedation

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.

You may not qualify if:

• enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Fux-Noy A, Saadi Q, Shmueli A, Halperson E, Ram D, Moskovitz M. Parents' satisfaction and children's acceptance of nasal compared to oral midazolam for sedation in two consecutive pediatric dental treatments: a randomized controlled study. Front Dent Med. 2023 Dec 21;4:1296823. doi: 10.3389/fdmed.2023.1296823. eCollection 2023.

  PMID: 39916898 DERIVED

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Avia Fux-Noy
• Organization: Hadassah School of Dental Medicine, P.O.Box 12272

fuxavia@gmail.com

+97226776135

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric dentist

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 10, 2016
• Study Start: March 28, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2022-01

Locations

IL (1)