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Completed

NCT Number: NCT03728894

Oral Sedation With and Without Nitrous Oxide

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.

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Key information

Conditions

Behavior, Child Behavior Child Behavior

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tishreen University

Latakia, Syria

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Midazolam-hydroxyzine with 100% O2

Drug

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.

Other names: A

Midazolam-hydroxyzine with 50% N2O/O2

Drug

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.

Other names: B

Primary outcomes

  1. Behavior improvement on the modified Houpt behavioral rating scale

    Time frame: 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

    Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.

  2. Behavior improvement on the modified Houpt behavioral rating scale

    Time frame: 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

    Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2018
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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