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

NCT01740492 | Completed Phase 1 DMC

• 1 other identifier: 298021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Ketamine; Acute pain; Pain control; Pain

Outcome Measures

Primary Outcomes (1)

• Change in reported pain score at 15 minutes, 30 minutes, and hourly for 6 hrs or until discharge

  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 research assistants (RA) 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: a rating of 0 corresponds to "no pain at all," whereas a rating of 10 is the "worst pain imaginable." Baseline NPRS will be measured after randomization, but just before administration of ketamine or placebo injection and morphine (Baseline). Repeat measurements will be taken at 15 minutes, 30 minutes, and hourly following treatment with the study drug, for 6hrs or until the patient leaves the ED. The amount of rescue analgesia will be recorded at each time point. The ED course will also be reviewed post hoc by the RAs and physician investigators to confirm analgesia received. The main outcome measure will be the change in pain score over time.

  Between patient arrival and patient discharge

Secondary Outcomes (1)

• 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.

  15 minutes, 30 minutes, hourly up to 6 hours

Study Arms (3)

LDK1: Low dose Ketamine (0.15mg/kg)

EXPERIMENTAL

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.

Drug: Ketamine 0.15mg/kg

LDK2: Low dose Ketamine (0.3mg/kg)

EXPERIMENTAL

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.

Drug: Ketamine 0.3mg/kg

0.9% Normal Saline

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ketamine 0.15mg/kg DRUG

0.15mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.

Also known as: Ketamine

LDK1: Low dose Ketamine (0.15mg/kg)

Ketamine 0.3mg/kg DRUG

0.3 mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.

Also known as: Ketamine

LDK2: Low dose Ketamine (0.3mg/kg)

Placebo OTHER

Placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)

0.9% Normal Saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain; Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Francesca Beaudoin, MD

  Rhode Island Hospital

  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: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 7, 2022

Record last verified: 2012-09

Locations

US (1)