Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department

Lifespan

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Ketamine 0.3mg/kg; Drug: Ketamine 0.15mg/kg; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01740492

298021

Details and patient eligibility

About

This study aims to address both the management and evaluation of pain. The primary aim of this study is to determine the efficacy of low dose ketamine in adults with moderate to severe pain in the emergency department as compared with parenteral opioids alone. Another aim is to examine the safety of low dose ketamine compared to opioids alone.

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 and assessment of pain in the Emergency Department (ED) can be challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, inadequate analgesia is often a problem when opioids alone are relied on for pain control. In the peri-operative setting ketamine has been used as an adjunct to opioids for acute pain. Ketamine may play a role in maximizing analgesia in the ED.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• Adults age 18-65
• 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
• ASA (American Society of Anesthesiologists) class I or II

Exclusion criteria

• Previously enrolled in the study
• Neurologic, respiratory, or hemodynamic compromise
• GCS (Glasgow Coma Scale) <15
• Pox <94%, RR <10, or RR >22
• SBP <90, SBP>180, or DBP >110
• Discretion of treating physician
• Pregnancy or breastfeeding
• Known or suspected allergy to ketamine or morphine
• Ketamine within 24 hours of presentation (prescription or illicit drugs)
• Conscious sedation in ED (per treating physician), includes ketamine (for non-study purposes)
• Known Renal (Cr>2.0) or Liver Failure
• Unstable psychiatric disease (as per treating physician)
• History of stroke
• History of cardiac disease
• Prior myocardial infarction; Angina (Stable or Unstable)
• Cardiac stents or bypass surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

LDK1: Low dose Ketamine (0.15mg/kg)

Experimental group

Description:

Participants randomized to the first group, LDK1, will receive an intravenous injection of low dose ketamine (0.15mg/kg). All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.

Treatment:

Drug: Ketamine 0.15mg/kg

LDK2: Low dose Ketamine (0.3mg/kg)

Experimental group

Description:

Participants randomized to the second group, LDK2, will receive an intravenous injection of low dose ketamine (0.3mg/kg). All participants, regardless of the group, will receive a dose of morphine(0.15mg/kg) at the same time the study drug is administered.

Treatment:

Drug: Ketamine 0.3mg/kg

0.9% Normal Saline

Placebo Comparator group

Description:

This group will receive a placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)

Treatment:

Other: Placebo