Clinical trial NCT03017248: Low-dose Ketamine for Acute Pain in the Emergency Department
Official title: Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain
Keywords: pain
ketamine
morphine
analgesia
emergency
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Two hours after starting protocol
Secondary outcomes:
measure: Total patient-perceived pain relief
timeFrame: Two hours after starting protocol
measure: Amount of rescue analgesia received
timeFrame: Two hours after starting protocol
measure: Time to rescue analgesia
timeFrame: Two hours after starting protocol
measure: The occurrence of adverse events
timeFrame: Two hours after starting protocol
measure: The total dose of morphine administered
timeFrame: Two hours after starting protocol
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Faculty of medicine of Sousse
Study officials:
affiliation: Faculty of medicine of Sousse
name: Hajer KRAIEM, MD
role: PRINCIPAL_INVESTIGATOR
References: