A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair

NCT01470157 | Unknown Phase 4

• 1 other identifier: 22/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: 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 a few studies oral ketamine has been used successfully for procedural sedation as well. The efficacy of using a combination of oral midazolam and oral ketamine for procedural sedation has been studied only for invasive procedures in children with malignancies. No randomized controedll studies were performed using this sedative combination in children requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to oral midazolam for procedural sedation in children requiring laceration repair compares to oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study. Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral ketamine group. Both groups will be given the same volume of medications. Midazolam will be given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given. Patient monitoring will be conducted according to the American Academy of Pediatrics (APP) and the Israeli health ministry guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Main outcome measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive statistics will be used to describe the study population. Data will be analyzed using t- tests for continuous data and Fisher exact test for categorical data. Key words: sedation, children, ketamine, midazolam, emergency department.

Conditions

Lacertaions

Outcome Measures

Primary Outcomes (1)

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

  participants will be followed for the duration of hospital stay, an expected average of 3 hours

Secondary Outcomes (1)

• Pain score: Visual analog score (VAS)- by a physician

  while in the ED for about 3 hours

Study Arms (2)

Ketamine

EXPERIMENTAL

Oral Ketamine in addition to oral midazolam

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Normal saline (placebo) in addition to oral midazolam

Drug: Normal Saline

Interventions

Ketamine DRUG

5mg/kg as oral suspension

Ketamine

Normal Saline DRUG

Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension

Placebo

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 1 years - 10 years
• Any child with laceration requiring sedation

You may not qualify if:

• 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
• ASA score of more than 2
• Informed consent cannot be obtained from legal guardian

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Pediatric Emergency Department

Assaf Harofeh, Zerifin, 70300, Israel

RECRUITING

Related Publications (1)

• Barkan S, Breitbart R, Brenner-Zada G, Feldon M, Assa A, Toledano M, Berkovitch S, Shavit I, Kozer E. A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair. Emerg Med J. 2014 Aug;31(8):649-53. doi: 10.1136/emermed-2012-202189. Epub 2013 May 18.

  PMID: 23686730 DERIVED

MeSH Terms

Interventions

Ketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Shiri Barkan, MD

CONTACT

972 544385404; shiri_barkan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Emergency Unit

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: November 11, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 11, 2011

Record last verified: 2011-11

Locations

IL (1)