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

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: Ketamine; Midazolam

Criteria

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