Low-dose Ketamine for Acute Pain in the Emergency Department

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03017248
• Date of registration: 09/01/2017
• Prospective Registration: No
• Primary sponsor: Faculty of Medicine, Sousse
• Public title: Low-dose Ketamine for Acute Pain in the Emergency Department
• Scientific title: Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
• Date of first enrolment: January 2016
• Target sample size: 125
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03017248
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Tunisia

Contacts

• Name: Hajer KRAIEM, MD
• Affiliation: Faculty of medicine of Sousse

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Morphine

Drug: Placebos

Drug: Ketamine

Primary Outcome(s)

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 [Time Frame: Two hours after starting protocol]

Secondary Outcome(s)

Time to rescue analgesia [Time Frame: Two hours after starting protocol]

Amount of rescue analgesia received [Time Frame: Two hours after starting protocol]

The occurrence of adverse events [Time Frame: Two hours after starting protocol]

Total patient-perceived pain relief [Time Frame: Two hours after starting protocol]

The total dose of morphine administered [Time Frame: Two hours after starting protocol]

Secondary ID(s)

FMSousse

Source(s) of Monetary Support

Please refer to primary and secondary sponsors