A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Phase 4
1 Year
10 Years
1 Year
10 Years
Open (Enrolling)
Both
Lacertaions
Both
Lacertaions
Trial Information
A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Inclusion Criteria:
- Age: 1 years - 10 years
- Any child with laceration requiring sedation
Exclusion Criteria:
- Major trauma
- Closed head injury associated with loss of consciousness
- Abnormal neurologic examination in a previously normal child
- Significant developmental delay or baseline neurological deficit
- A patient with seizures
- Elevated intra-cranial pressure
- Hypersensitivity to midazolam or ketamine
- Hypertension
- Hyperthyroidism or a patient receiving thyroid replacement
- alcohol intoxication or a history of alcohol abuse
- Acute or chronic respiratory, cardiac, renal or hepatic abnormalities
- Glaucoma
- Known psychiatric disease
- ASA score of more than 2
- Informed consent cannot be obtained from legal guardian
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Pain score: Visual analog score (VAS)- by parent
Outcome Time Frame:
participants will be followed for the duration of hospital stay, an expected average of 3 hours
Safety Issue:
Yes
Authority:
Israel: Ministry of Health
Study ID:
22/11
NCT ID:
NCT01470157
Start Date:
July 2011
Completion Date:
July 2012
Related Keywords:
- Lacertaions
- Lacerations
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