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

NCT ID: NCT01470157

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Lacertaions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

Oral Ketamine in addition to oral midazolam

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

5mg/kg as oral suspension

Placebo

Normal saline (placebo) in addition to oral midazolam

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension

Interventions

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Ketamine

5mg/kg as oral suspension

Intervention Type DRUG

Normal Saline

Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Director, Pediatric Emergency Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Emergency Department

Assaf Harofeh, Zerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shiri Barkan, MD

Role: CONTACT

[email protected]
972 544385404

Facility Contacts

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Shiri Barkan, MD

Role: primary

[email protected]
972 544385404

References

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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.

Reference Type DERIVED
PMID: 23686730 (View on PubMed)

Other Identifiers

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22/11

Identifier Type: -

Identifier Source: org_study_id