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Low-dose Ketamine for Acute Pain in the Emergency Department

NCT ID: NCT03017248

Last Updated: 2017-01-31

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

PHASE1

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.

The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.

Detailed Description

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Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.

Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.

Its use in the ED may probably play a role in maximizing analgesia.

Conditions

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Pain

Keywords

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pain ketamine morphine analgesia emergency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Morphine and Placebo

Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)

Group Type ACTIVE_COMPARATOR

Placebos

Intervention Type DRUG

0.9% normal saline

Morphine

Intervention Type DRUG

Morphine

Morphine and Ketamine 0.15

Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine

Morphine

Intervention Type DRUG

Morphine

Morphine and Ketamine 0.3

Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine

Morphine

Intervention Type DRUG

Morphine

Interventions

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Ketamine

ketamine

Intervention Type DRUG

Placebos

0.9% normal saline

Intervention Type DRUG

Morphine

Morphine

Intervention Type DRUG

Other Intervention Names

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Ketalar, 50 Mg/mL Injectable Solution Normal Saline Flush, 0.9% Injectable Solution Morphine Sulfate

Eligibility Criteria

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Inclusion Criteria

* Able to understand and give informed consent
* Comfortable with the experimental protocol as outlined to them by the research team
* Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
* Acute pain, pain duration \< 7days
* Deemed by treating ED attending physician to require IV opioid analgesia

Exclusion Criteria

* Neurologic, respiratory, or hemodynamic compromise
* Pregnancy or breastfeeding
* Known or suspected allergy to ketamine or morphine
* Known Renal (Cr\>2.0) or Liver Failure
* Unstable psychiatric disease (as per treating physician)
* History of stroke
* History of cardiac disease or coronary artery disease
* History of chronic respiratory disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Medicine, Sousse

OTHER

Sponsor Role lead

Responsible Party

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HAJER KRAIEM

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hajer KRAIEM, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine of Sousse

Locations

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Faculty of medicine of Sousse

Sousse, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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FMSousse

Identifier Type: -

Identifier Source: org_study_id