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

Phase 4UnknownNCT01925898

Assaf-Harofeh Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lacerations

Interventions

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 Years

Medical Language ↔ Plain English

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