A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Overview
- Phase
- Phase 4
- Intervention
- Midazolam - active comparator
- Conditions
- Lacerations
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain score: Visual analog score (VAS)- by a parent
- Last Updated
- 12 years ago
Overview
Brief Summary
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 laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery
Hypothesis:
Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Midazolam
Oral Midazolam
Intervention: Midazolam - active comparator
Outcomes
Primary Outcomes
Pain score: Visual analog score (VAS)- by a parent
Time Frame: During the procedure - up to 1 hour
A parent will assess the child's pain on a Visual analog scale
Number of patients requiring IV sedation
Time Frame: During the procedure - up to 1 hour
patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation
Secondary Outcomes
- • Patients and parents satisfaction assessed on VAS(While in the ED - estimated time around 2 hours)
- UMSS - by ED physician(During the procedure - up to 1 hour)
- • VAS by nurse(During the procedure - up to 1 hour)
- Time to reach UMSS > 2(up to 1 hour)
- • Procedure time(During the procedure - up to 1 hour)
- • Time from procedure to full recovery(While in the ED - estimated time around 2 hours)
- The occurrence of adverse effects during the ED stay(While in the ED - estimated time around 2 hours)