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

Lacerations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01925898
• Other study ID #: 87/13
• Status: Recruiting
• Phase: Phase 4
• First received: July 17, 2013
• Last updated: January 20, 2014
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2013
• Source: Assaf-Harofeh Medical Center
• Contact: Eran Kozer, MD
• Phone: 972-8-9779916
• Email: erank[@]assaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lacerations

Intervention

Drug:
• Midazolam - active comparator
Oral midazolam - 0.7mg/kg single dose
• Experimental Arm: Ketamine
Oral Ketamine 5mg/kg Single dose

Locations

Country	Name	City	State
Israel	Assaf Harofeh MC	Be'er Ya`aqov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score: Visual analog score (VAS)- by a parent	A parent will assess the child's pain on a Visual analog scale	During the procedure - up to 1 hour	No
Primary	Number of patients requiring IV sedation	patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation	During the procedure - up to 1 hour	No
Secondary	UMSS - by ED physician		During the procedure - up to 1 hour	No
Secondary	• VAS by nurse		During the procedure - up to 1 hour	No
Secondary	Time to reach UMSS > 2		up to 1 hour	No
Secondary	• Procedure time		During the procedure - up to 1 hour	No
Secondary	• Time from procedure to full recovery		While in the ED - estimated time around 2 hours	No
Secondary	The occurrence of adverse effects during the ED stay	Significant adverse effects are defined as; Oxygen desaturation <92% or hypoventilation requiering ventilatory support; Need for hemodynamic support; Anaphylaxis; Seizures; Any adverse effects requiring patient admission	While in the ED - estimated time around 2 hours	Yes
Secondary	• Patients and parents satisfaction assessed on VAS		While in the ED - estimated time around 2 hours	No