Trial record 4 of 119 for:    Open Studies | "Lacerations"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01925898
First received: July 17, 2013
Last updated: January 20, 2014
Last verified: August 2013
  Purpose

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 Intervention Phase
Lacerations
Drug: Midazolam - active comparator
Drug: Experimental Arm: Ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Pain score: Visual analog score (VAS)- by a parent [ Time Frame: During the procedure - up to 1 hour ] [ Designated as safety issue: No ]
    A parent will assess the child's pain on a Visual analog scale

  • Number of patients requiring IV sedation [ Time Frame: During the procedure - up to 1 hour ] [ Designated as safety issue: No ]
    patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation


Secondary Outcome Measures:
  • UMSS - by ED physician [ Time Frame: During the procedure - up to 1 hour ] [ Designated as safety issue: No ]
  • • VAS by nurse [ Time Frame: During the procedure - up to 1 hour ] [ Designated as safety issue: No ]
  • Time to reach UMSS > 2 [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
  • • Procedure time [ Time Frame: During the procedure - up to 1 hour ] [ Designated as safety issue: No ]
  • • Time from procedure to full recovery [ Time Frame: While in the ED - estimated time around 2 hours ] [ Designated as safety issue: No ]
  • The occurrence of adverse effects during the ED stay [ Time Frame: While in the ED - estimated time around 2 hours ] [ Designated as safety issue: Yes ]

    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

  • • Patients and parents satisfaction assessed on VAS [ Time Frame: While in the ED - estimated time around 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925898

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

Locations
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

No publications provided

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01925898     History of Changes
Other Study ID Numbers: 87/13
Study First Received: July 17, 2013
Last Updated: January 20, 2014
Health Authority: Israel: Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
Laceration
Sedation
Pediatrics

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Ketamine
Midazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 21, 2014