IRCT2014010616106N1
Completed
Phase 4
Comparing the sedative effect of oral Midazolam/Hydroxyzine vs Chloral hydrate/Hydroxizine in behavior control of 6-10 year old uncooperative children.
Iran Center for Dental Research, Shahid Beheshti Medical University0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Iran Center for Dental Research, Shahid Beheshti Medical University
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •cases with a behavioral score of 2 in Frankel scale system (Uncooperative); those with at least two similar dental needs; ages of 6\-10 years old; able to attend two visits scheduled for dental treatments; able to keep 4 hours NPO prior to sedation.
- •Exclusion criteria: clear from any medical condition (out of the ASA I \& II); taking any sedative, narcotic or CNS depressant drug; those who have cold or other respiratory obstruction; those having fever of known or unknown origin; unable to observe 4 hours of NPO; unable to accept the drugs administered due to taste or volume.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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