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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Oral ketamine |
|
| Midazolam | Active Comparator | Oral Midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam - active comparator | Drug | Oral midazolam - 0.7mg/kg single dose |
|
| 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 |
| 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 |
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Inclusion Criteria:
• Any child with laceration requiring sedation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eran Kozer, MD | Contact | 972-8-9779916 | erank@assaf.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh MC | Recruiting | Be’er Ya‘aqov | Israel |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Experimental Arm: Ketamine | Drug | Oral Ketamine 5mg/kg Single dose |
|
|
| 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
| 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 |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |