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

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ClinicalTrials.gov Identifier: NCT01925898
Recruitment Status : Unknown
Verified August 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : August 20, 2013
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Lacerations Drug: Midazolam - active comparator Drug: Experimental Arm: Ketamine Phase 4

Study Design
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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 Versus Oral Ketamine for Sedation During Laceration Repair.
Study Start Date : August 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine
Oral ketamine
 Drug: Experimental Arm: Ketamine
Oral Ketamine 5mg/kg Single dose
Other Name: Ketalar
Active Comparator: Midazolam
Oral Midazolam
 Drug: Midazolam - active comparator
Oral midazolam - 0.7mg/kg single dose
Other Name: Dormicum


Outcome Measures
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Primary Outcome Measures :
  1. Pain score: Visual analog score (VAS)- by a parent [ Time Frame: During the procedure - up to 1 hour ]
    A parent will assess the child's pain on a Visual analog scale

  2. Number of patients requiring IV sedation [ Time Frame: During the procedure - up to 1 hour ]
    patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation


Secondary Outcome Measures :
  1. UMSS - by ED physician [ Time Frame: During the procedure - up to 1 hour ]
  2. • VAS by nurse [ Time Frame: During the procedure - up to 1 hour ]
  3. Time to reach UMSS > 2 [ Time Frame: up to 1 hour ]
  4. • Procedure time [ Time Frame: During the procedure - up to 1 hour ]
  5. • Time from procedure to full recovery [ Time Frame: While in the ED - estimated time around 2 hours ]
  6. The occurrence of adverse effects during the ED stay [ Time Frame: While in the ED - estimated time around 2 hours ]

    Significant adverse effects are defined as

    1. Oxygen desaturation <92% or hypoventilation requiering ventilatory support
    2. Need for hemodynamic support
    3. Anaphylaxis
    4. Seizures
    5. Any adverse effects requiring patient admission

  7. • Patients and parents satisfaction assessed on VAS [ Time Frame: While in the ED - estimated time around 2 hours ]

Eligibility Criteria
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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:

• 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
Contacts and Locations
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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): NCT01925898


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

Locations
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Israel
Assaf Harofeh MC Recruiting
Be'er Ya`aqov, Israel
Contact: Orit Rubinstein, MD    972-8-9779916    oritar78@gmail.com   
Sub-Investigator: Orit Rubinstein, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01925898     History of Changes
Other Study ID Numbers: 87/13
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: August 2013
Keywords provided by Assaf-Harofeh Medical Center:
Laceration
Sedation
Pediatrics
Additional relevant MeSH terms:
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Lacerations
Wounds and Injuries
Midazolam
Ketamine
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