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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

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.


Condition or disease Intervention/treatment Phase
Lacertaions Drug: Ketamine Drug: Normal Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Study Start Date : July 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Ketamine
Oral Ketamine in addition to oral midazolam
Drug: Ketamine
5mg/kg as oral suspension

Placebo Comparator: Placebo
Normal saline (placebo) in addition to oral midazolam
Drug: Normal Saline
Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pain score: Visual analog score (VAS)- by a physician [ Time Frame: while in the ED for about 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470157


Contacts
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Contact: Shiri Barkan, MD 972 544385404 shiri_barkan@yahoo.com

Locations
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Israel
Pediatric Emergency Department Recruiting
Assaf Harofeh, Zerifin, Israel, 70300
Contact: Shiri Barkan, MD    972 544385404    shiri_barkan@yahoo.com   
Principal Investigator: Shiri Barkan, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assaf Harofeh MC, Director, Pediatric Emergency Unit, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01470157     History of Changes
Other Study ID Numbers: 22/11
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries
Ketamine
Midazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents