Lacerations
Conditions
Keywords
Laceration, Sedation, Pediatrics
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.
Interventions
DRUGMidazolam - active comparator
Oral midazolam - 0.7mg/kg single dose
DRUGExperimental Arm: Ketamine
Oral Ketamine 5mg/kg Single dose
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score: Visual analog score (VAS)- by a parent | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to reach UMSS > 2 | up to 1 hour | — |
| • Procedure time | During the procedure - up to 1 hour | — |
| UMSS - by ED physician | During the procedure - up to 1 hour | — |
| The occurrence of adverse effects during the ED stay | While in the ED - estimated time around 2 hours | 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 |
| • Patients and parents satisfaction assessed on VAS | While in the ED - estimated time around 2 hours | — |
| • Time from procedure to full recovery | While in the ED - estimated time around 2 hours | — |
| • VAS by nurse | During the procedure - up to 1 hour | — |
Countries
Israel
Contacts
Primary ContactEran Kozer, MD
Outcome results
None listed