sedative effect of intranasal ketamine/midazolam on 3-6 year old children behavior in pediatric dentistry

Early Phase 1

• Conditions: F98-F90; Anxiety.; F13

• Registration Number: IRCT201305101882N3
• Lead Sponsor: Dental Research Center,Research Institute of Dental sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1-Frankle 1,2 uncooperative child
2-ASA 1,2 healthy child
3-Needs to at least 2 treatment session
Exclusion criteria:
1- Nasal obturation
2- Respratory infection
3-Tonsile hypertrophy
4-Macroglosia

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleeping. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Crying. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Movement. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.;Overall Behavior. Timepoint: After effect of drug, 15 and 30 minutes. Method of measurement: Observation and Houpt Scale.

Secondary Outcome Measures

Name	Time	Method
Heart Rate. Timepoint: Befor treatment, after effect of drug, 15and 30 minutes. Method of measurement: Pulse oxymeter.;Spo2. Timepoint: Befor treatment, after effect of drug, 15and 30 minutes. Method of measurement: Pulse oxymeter.