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

NCT ID: NCT01740492

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LDK1: Low dose Ketamine (0.15mg/kg)

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.

Group Type: EXPERIMENTAL

Ketamine 0.15mg/kg

Intervention Type: DRUG

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

LDK2: Low dose Ketamine (0.3mg/kg)

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.

Group Type: EXPERIMENTAL

Ketamine 0.3mg/kg

Intervention Type: 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.

0.9% Normal Saline

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Ketamine 0.15mg/kg

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

Intervention Type: DRUG

Ketamine 0.3mg/kg

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Ketamine; Ketamine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesca Beaudoin, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

298021

Identifier Type: -

Identifier Source: org_study_id