A Phase 4 interventional study of Midazolam - active comparator and Experimental Arm: Ketamine in Lacerations, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Assaf-Harofeh Medical Center · Phase 4, Interventional, and Treatment
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.
140 studies on the registry are indexed under Lacerations; 30 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 111 interventional studies indexed under Lacerations.
Browse Lacerations studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Oral ketamine
Drug: Experimental Arm: Ketamine
Oral Midazolam
Drug: Midazolam - active comparator
Oral midazolam - 0.7mg/kg single dose
Also known as: Dormicum
Oral Ketamine 5mg/kg Single dose
Also known as: Ketalar
Pain score: Visual analog score (VAS)- by a parent
A parent will assess the child's pain on a Visual analog scale
Time frame: During the procedure - up to 1 hour
Number of patients requiring IV sedation
patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation
Time frame: During the procedure - up to 1 hour
UMSS - by ED physician
Time frame: During the procedure - up to 1 hour
• VAS by nurse
Time frame: During the procedure - up to 1 hour
Time to reach UMSS > 2
Time frame: up to 1 hour
• Procedure time
Time frame: During the procedure - up to 1 hour
• Time from procedure to full recovery
Time frame: While in the ED - estimated time around 2 hours
The occurrence of adverse effects during the ED stay
Significant adverse effects are defined as 1. Oxygen desaturation \<92% or hypoventilation requiering ventilatory support 2. Need for hemodynamic support 3. Anaphylaxis 4. Seizures 5. Any adverse effects requiring patient admission
Time frame: While in the ED - estimated time around 2 hours
• Patients and parents satisfaction assessed on VAS
Time frame: While in the ED - estimated time around 2 hours
The record gives a start of Aug 2013, a primary completion of Feb 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
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