Low-dose Ketamine for Acute Pain in the Emergency Department

NCT03017248 | Unknown Phase 1 DMC

• 1 other identifier: FMSousse
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

pain; ketamine; morphine; analgesia; emergency

Outcome Measures

Primary Outcomes (1)

• Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours

  At baseline, to assess our primary aim, efficacy of pain control, we will use patient reported pain scores and amount of rescue analgesia (parenteral morphine) received. Trained residents will ask participants to report their pains scores using a numerical pain rating scale (NPRS). The NPRS used will be a 0 to 10 rating scale. Baseline NPRS will be measured after randomization, but just before administration of morphine. Change in reported pain score during the protocol will be analysed. The SPID was calculated using the pain-intensity difference (PID) at each of these study time points. The PID for a given time point is equal to the baseline NPRS minus the subsequent NPRS at each study time point. SPID is the summation of the PID at each of the study time points, weighted using the amount of time since the prior assessment

  Two hours after starting protocol

Secondary Outcomes (5)

• Total patient-perceived pain relief

  Two hours after starting protocol

• Amount of rescue analgesia received

  Two hours after starting protocol

• Time to rescue analgesia

  Two hours after starting protocol

• The occurrence of adverse events

  Two hours after starting protocol

• The total dose of morphine administered

  Two hours after starting protocol

Study Arms (3)

Morphine and Placebo

ACTIVE COMPARATOR

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

Drug: Placebos; Drug: Morphine

Morphine and Ketamine 0.15

EXPERIMENTAL

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

Drug: Ketamine; Drug: Morphine

Morphine and Ketamine 0.3

EXPERIMENTAL

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

Drug: Ketamine; Drug: Morphine

Interventions

Ketamine DRUG

ketamine

Also known as: Ketalar, 50 Mg/mL Injectable Solution

Morphine and Ketamine 0.15; Morphine and Ketamine 0.3

Placebos DRUG

0.9% normal saline

Also known as: Normal Saline Flush, 0.9% Injectable Solution

Morphine and Placebo

Morphine DRUG

Morphine

Also known as: Morphine Sulfate

Morphine and Ketamine 0.15; Morphine and Ketamine 0.3; Morphine and Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Faculty of medicine of Sousse

Sousse, 4002, Tunisia

Location

MeSH Terms

Conditions

Pain; Agnosia; Emergencies

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hajer KRAIEM, MD

  Faculty of medicine of Sousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: March 1, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

TU (1)