Low-dose Ketamine for Acute Pain in the Emergency Department

Faculty of Medicine, Sousse

Status and phase: Unknown; Phase 1

Conditions: Pain

Treatments: Drug: Morphine; Drug: Ketamine; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03017248

FMSousse

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 3 patient groups

Morphine and Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Placebos

Drug: Morphine

Morphine and Ketamine 0.15

Experimental group

Description:

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

Treatment:

Drug: Ketamine

Drug: Morphine

Morphine and Ketamine 0.3

Experimental group

Description:

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

Treatment:

Drug: Ketamine

Drug: Morphine