Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Information source: Rhode Island Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Ketamine 0.15mg/kg (Drug); Ketamine 0.3mg/kg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Rhode Island Hospital Official(s) and/or principal investigator(s):
Francesca Beaudoin, MD, Principal Investigator, Affiliation: Rhode Island Hospital
Summary
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.
Clinical Details
Official title: Low Dose Ketamine for Management of Acute Severe Pain in the Emergency Department
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge
Secondary outcome: Safety--Determine the incidence of adverse events associated with ketamine and morphine, versus morphine alone at 5 minutes, 30 minutes, and hourly up to 6 hours.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Additional Information
Starting date: September 2012
Last updated: June 19, 2014
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