Oral Sedation With and Without Nitrous Oxide

Behavior, Child Clinical Trial

Official title:

Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728894
• Other study ID #: Tishreen-sedation
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2018
• Est. completion date: January 6, 2019

Study information

• Verified date: January 2019
• Source: Tishreen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.

Description:

The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 6, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Criteria: Inclusion Criteria:

• ASA Classification I.

• minimum weight of 18 kg

• uncooperative children scored 1 or 2 on Frankle Scale.

• requiring nonemergency, bilateral mandibular dental treatments under local anesthesia.

Exclusion Criteria:

• known allergy to midazolam and/or hydroxyzine.

• upper respiratory tract infection with nasal discharge.

Related Conditions & MeSH terms

• Behavior, Child

Intervention

Drug:
• Midazolam-hydroxyzine with 100% O2
Patients received Oral Sedatives with 100% O2 ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
• Midazolam-hydroxyzine with 50% N2O/O2
Patients received Oral Sedatives with 50% nitrous ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior improvement on the modified Houpt behavioral rating scale	Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.	Behavior will assess at the end of the session (about 30-90 min) by evaluating the sessions 's videotapes using overall assessment (range from 1 to 4, higher values represent a better outcome) of the modified Houpt behavioral rating scale
Primary	Behavior improvement on the modified Houpt behavioral rating scale	Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.	Behavior assess after 30 min of oral medications administered by evaluate the sessions's videotapes using of Sleep,movement,Head/oral resistance,Cry,Verbal assessments(range1- 4,higher values is the better outcome)of modified Houpt behavioral scale