A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Conditions
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Lacerations

Intervention / Treatment
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* Drug: Midazolam - active comparator
* Drug: Experimental Arm: Ketamine


Participation Criteria
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Eligibility Criteria
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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 Acute or chronic respiratory, cardiac, renal or hepatic abnormalities Glaucoma Known psychiatric disease American Society of Anesthesiologists (ASA) score of more than 2 Informed consent cannot be obtained from legal guardian

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Oral ketamine | Drug: Experimental Arm: Ketamine<br>* Oral Ketamine 5mg/kg Single dose<br>* Other names: Ketalar;|
| Active Comparator: Midazolam<br>Oral Midazolam | Drug: Midazolam - active comparator<br>* Oral midazolam - 0.7mg/kg single dose<br>* Other names: Dormicum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score: Visual analog score (VAS)- by a parent | A parent will assess the child's pain on a Visual analog scale | 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 | During the procedure - up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Significant adverse effects are defined as Oxygen desaturation <92% or hypoventilation requiering ventilatory support Need for hemodynamic support Anaphylaxis Seizures Any adverse effects requiring patient admission | While in the ED - estimated time around 2 hours | 
| • Patients and parents satisfaction assessed on VAS |  | While in the ED - estimated time around 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Laceration, Sedation