Behavior, Child
Conditions
Keywords
Midazolam, hydroxyzine, oxygen, behavior, child, tooth
Brief 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.
Detailed 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).
Interventions
DRUGMidazolam-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.
DRUGMidazolam-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.
Sponsors
Tishreen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Triple (Participant, Care Provider, Outcomes Assessor) Each of the children/parents, the dentist and the outcomes assessors were blinded. To ensure the blindness of the dentist, the inhalation sedation machine was placed in a way that he could not see the flow rate panel or the type of the administered gases.
Intervention model description
blinded, randomized controlled trial, comparing two groups.
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavior improvement on the modified Houpt behavioral rating scale | 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. |
Countries
Syria
Outcome results
None listed