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

Phase 4

• Conditions: Lacerations
• Interventions: Drug: Midazolam - active comparator

• Registration Number: NCT01925898
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-17
• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-18
• Study First Posted: 2013-08-20
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-02
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Midazolam - active comparator	Oral Midazolam

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• Patients and parents satisfaction assessed on VAS	While in the ED - estimated time around 2 hours
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	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	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

Trial Locations

Locations (1)

Assaf Harofeh MC; 🇮🇱 Be'er Ya'aqov, Israel