Evaluation of the effect of oral chloral hydrate and intranasal midazolam on sedation of childre
Phase 3
Recruiting
- Conditions
- Head trauma.Superficial injury of head
- Registration Number
- IRCT20180129038549N4
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
The child is alert with head trauma requires CT scan of head
Lack of cooperation for CT scan
American Society ofAnesthesiology (ASA) class 1 or 2
Exclusion Criteria
Receiving a sedative hypnotic agent within thepast 48 hours
Gastritis
Serious systemic disease
Nasal allergy to drugs
Obesity (body mass index.30)
Known contraindications to theuse of study drugs (eg, hypersensitivity),
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation level of the patient. A score of four is considered. Timepoint: Every 5 minutes. Method of measurement: Physical exam.;Success in CT scan doing. Timepoint: After refer to the radiology department. Method of measurement: Performing or not performing a CT scan.
- Secondary Outcome Measures
Name Time Method Side effects. Timepoint: every 5 minutes. Method of measurement: Physical exam.;Vital signs (blood oxygen saturation level, pulse rate and respiratory rate per minute). Timepoint: Every 5 minutes. Method of measurement: Physical exam.;The time interval from taking the drugs to the adequate sedation. Timepoint: Every 5 minutes. Method of measurement: Ramsay sedation scale.;The interval time between drug taking and CT scan performing. Timepoint: Every 5 minutes. Method of measurement: Record time.;The time interval from taking the drug to the child's full consciousness. Timepoint: Every 5 minutes. Method of measurement: Record time.;The parents' satisfaction. Timepoint: After the child's consciousness. Method of measurement: Question from parents.