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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 4

Conditions: Lacerations

Treatments: Drug: Experimental Arm: Ketamine; Drug: Midazolam - active comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT01925898

87/13

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Ketamine

Experimental group

Description:

Oral ketamine

Treatment:

Drug: Experimental Arm: Ketamine

Midazolam

Active Comparator group

Description:

Oral Midazolam

Treatment:

Drug: Midazolam - active comparator