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

Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lacerations

Intervention: Midazolam - active comparator (Drug); Experimental Arm: Ketamine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Assaf-Harofeh Medical Center

Overall contact:
Eran Kozer, MD, Phone: 972-8-9779916, Email: erank@assaf.health.gov.il


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.

Clinical Details

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

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

Primary outcome:

Pain score: Visual analog score (VAS)- by a parent

Number of patients requiring IV sedation

Secondary outcome:

UMSS - by ED physician

• VAS by nurse

Time to reach UMSS > 2

• Procedure time

• Time from procedure to full recovery

The occurrence of adverse effects during the ED stay

• Patients and parents satisfaction assessed on VAS


Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.


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

Locations and Contacts

Eran Kozer, MD, Phone: 972-8-9779916, Email: erank@assaf.health.gov.il

Assaf Harofeh MC, Be'er Ya`aqov, Israel; Recruiting
Orit Rubinstein, MD, Phone: 972-8-9779916, Email: oritar78@gmail.com
Orit Rubinstein, MD, Sub-Investigator
Additional Information

Starting date: August 2013
Last updated: January 20, 2014

Page last updated: August 23, 2015

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