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

Primary Purpose

Lacerations

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Midazolam - active comparator
Experimental Arm: Ketamine
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacerations focused on measuring Laceration, Sedation, Pediatrics

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Midazolam

Arm Description

Oral ketamine

Oral Midazolam

Outcomes

Primary Outcome Measures

Pain score: Visual analog score (VAS)- by a parent
A parent will assess the child's pain on a Visual analog scale
Number of patients requiring IV sedation
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
• VAS by nurse
Time to reach UMSS > 2
• Procedure time
• Time from procedure to full recovery
The occurrence of adverse effects during the ED stay
Significant adverse effects are defined as Oxygen desaturation <92% or hypoventilation requiering ventilatory support Need for hemodynamic support Anaphylaxis Seizures Any adverse effects requiring patient admission
• Patients and parents satisfaction assessed on VAS

Full Information

First Posted
July 17, 2013
Last Updated
January 20, 2014
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01925898
Brief Title
A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Official Title
A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacerations
Keywords
Laceration, Sedation, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Oral ketamine
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Oral Midazolam
Intervention Type
Drug
Intervention Name(s)
Midazolam - active comparator
Other Intervention Name(s)
Dormicum
Intervention Description
Oral midazolam - 0.7mg/kg single dose
Intervention Type
Drug
Intervention Name(s)
Experimental Arm: Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Oral Ketamine 5mg/kg Single dose
Primary Outcome Measure Information:
Title
Pain score: Visual analog score (VAS)- by a parent
Description
A parent will assess the child's pain on a Visual analog scale
Time Frame
During the procedure - up to 1 hour
Title
Number of patients requiring IV sedation
Description
patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation
Time Frame
During the procedure - up to 1 hour
Secondary Outcome Measure Information:
Title
UMSS - by ED physician
Time Frame
During the procedure - up to 1 hour
Title
• VAS by nurse
Time Frame
During the procedure - up to 1 hour
Title
Time to reach UMSS > 2
Time Frame
up to 1 hour
Title
• Procedure time
Time Frame
During the procedure - up to 1 hour
Title
• Time from procedure to full recovery
Time Frame
While in the ED - estimated time around 2 hours
Title
The occurrence of adverse effects during the ED stay
Description
Significant adverse effects are defined as Oxygen desaturation <92% or hypoventilation requiering ventilatory support Need for hemodynamic support Anaphylaxis Seizures Any adverse effects requiring patient admission
Time Frame
While in the ED - estimated time around 2 hours
Title
• Patients and parents satisfaction assessed on VAS
Time Frame
While in the ED - estimated time around 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Kozer, MD
Phone
972-8-9779916
Email
erank@assaf.health.gov.il
Facility Information:
Facility Name
Assaf Harofeh MC
City
Be'er Ya'aqov
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orit Rubinstein, MD
Phone
972-8-9779916
Email
oritar78@gmail.com
First Name & Middle Initial & Last Name & Degree
Orit Rubinstein, MD

12. IPD Sharing Statement

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

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