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

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ClinicalTrials.gov Identifier: NCT01470157
Recruitment Status : Unknown
Verified November 2011 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : November 11, 2011
Last Update Posted : November 11, 2011
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE September 19, 2011
First Posted Date  ICMJE November 11, 2011
Last Update Posted Date November 11, 2011
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
Pain score: Visual analog score (VAS)- by parent [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
Pain score: Visual analog score (VAS)- by a physician [ Time Frame: while in the ED for about 3 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Official Title  ICMJE A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lacertaions
Intervention  ICMJE
  • Drug: Ketamine
    5mg/kg as oral suspension
  • Drug: Normal Saline
    Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension
Study Arms  ICMJE
  • Experimental: Ketamine
    Oral Ketamine in addition to oral midazolam
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Normal saline (placebo) in addition to oral midazolam
    Intervention: Drug: Normal Saline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 9, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 1 years - 10 years
  • 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
  • ASA score of more than 2
  • Informed consent cannot be obtained from legal guardian
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01470157
Other Study ID Numbers  ICMJE 22/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assaf Harofeh MC, Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assaf-Harofeh Medical Center
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP