Status:
UNKNOWN
A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Lacertaions
Eligibility:
All Genders
1-10 years
Phase:
PHASE4
Brief Summary
Background: Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing l...
Eligibility Criteria
Inclusion
- Age: 1 years - 10 years
- Any child with laceration requiring sedation
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01470157
Start Date
July 1 2011
End Date
July 1 2012
Last Update
November 11 2011
Active Locations (1)
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1
Pediatric Emergency Department
Assaf Harofeh, Zerifin, Israel, 70300