Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department

NCT02489630 | Completed Phase 4 Results

• 1 other identifier: 08302015
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates the use of low doses of ketamine, along with opiate pain medication, is more effective at controlling the acute pain of patients in the emergency department than opiate pain medication alone. In addition, this study examines whether patients treated with low doses of ketamine, along with opiate pain medication, will require less opiate pain medication to control their pain, and whether these patients are equally happy with their pain control as patients who receive only opiate pain medication.

Conditions

Acute Pain; Pain

Outcome Measures

Primary Outcomes (2)

• Change in Level of Pain Control as Reported on the NRS-11

  Patient-reported pain scores on numerical rating scale (NRS) -11 pain scale (where 0 indicates no pain at all, 10 indicates the most severe pain). "Initial" group were patients enrolled and randomized in to the study, assessments were taken at the time of enrollment/randomization in to the study (up to 20 min prior to T=0). T = 0 min assessments were conducted at the time of medication administration (study allowed for an up to 20-minute delay in receiving study drug in order to retrieve study drug from secure storage, nursing documentation and patient verification prior to administration).

  20 min pre-medication administration, 0 min, 30 min, 60 min, 90 min, 120 min post medication administration

• Change in Patient Satisfaction With Pain Control on a 1-4 Likert Scale

  Patient-reported score regarding satisfaction with pain control, reported on a 4-point Likert scale (1-4, where 1 is the lowest satisfaction score possible and 4 is the highest satisfaction score possible). No data is reported for T = 0 min, as that assessment was conducted concurrently with initial medication dosing (since patients were at that point receiving their first pain control efforts, they could not yet assess their satisfaction with those efforts).

  0 min, 30 min, 60 min, 90 min, 120 min post medication administration

Secondary Outcomes (1)

• Difference in Opiate Dosage Between Study Arms in Morphine Equivalents

  20 mins pre-medication administration, 0 min, 30 min, 60 min, 90 min, 120 min post medication administration

Study Arms (2)

Ketamine

EXPERIMENTAL

0.1 mg/kg ketamine + opiate analgesic

Drug: Ketamine; Drug: opiate analgesic

Placebo

PLACEBO COMPARATOR

0.1 mL/kg normal saline + opiate analgesic

Drug: Normal Saline; Drug: opiate analgesic

Interventions

Ketamine DRUG

0.1mg/kg ketamine IV

Also known as: Ketalar

Ketamine

Normal Saline DRUG

1ml/kg normal saline placebo

Also known as: NS, saline

Placebo

opiate analgesic DRUG

0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request

Ketamine; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years but less than 70 years old.
• Exhibiting pain defined on a numerical rating scale (NRS-11 \[Farrar et al. 2001\]) score of equal to or greater than 6 out of 10
• Deemed by the treating EM physician to require opioid analgesia.

You may not qualify if:

• Respiratory, hemodynamic or neurologic compromise, as determined by observation of signs of respiratory distress, systolic blood pressure less than 90 mmHg or systolic/diastolic blood pressure greater than 160/90, or a Glasgow -Coma Score less than 15.
• A history of chronic ventilation, dialysis or with previously diagnosed cirrhosis or hepatitis by istory.
• Active psychosis.
• Clinical intoxication.
• Known sensitivity to any study drug.
• An inability to understand the NRS-11 pain measurement scale.
• Presentation with headache or chest pain.
• Pregnancy.
• A lack of decision-making capacity.
• A pain score less than 6 on the NRS-11 scale.
• A concern by the treating physician or study personnel of current or prior history of narcotic abuse, or other secondary gain.
• Previously participated in the study.

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator
• University of Memphis: collaborator

Related Publications (6)

• Ahern TL, Herring AA, Stone MB, Frazee BW. Effective analgesia with low-dose ketamine and reduced dose hydromorphone in ED patients with severe pain. Am J Emerg Med. 2013 May;31(5):847-51. doi: 10.1016/j.ajem.2013.02.008. Epub 2013 Apr 18.

  PMID: 23602757 BACKGROUND

• Beaudoin FL, Lin C, Guan W, Merchant RC. Low-dose ketamine improves pain relief in patients receiving intravenous opioids for acute pain in the emergency department: results of a randomized, double-blind, clinical trial. Acad Emerg Med. 2014 Nov;21(11):1193-202. doi: 10.1111/acem.12510.

  PMID: 25377395 BACKGROUND

• Galinski M, Dolveck F, Combes X, Limoges V, Smail N, Pommier V, Templier F, Catineau J, Lapostolle F, Adnet F. Management of severe acute pain in emergency settings: ketamine reduces morphine consumption. Am J Emerg Med. 2007 May;25(4):385-90. doi: 10.1016/j.ajem.2006.11.016.

  PMID: 17499654 BACKGROUND

• Jennings PA, Cameron P, Bernard S, Walker T, Jolley D, Fitzgerald M, Masci K. Morphine and ketamine is superior to morphine alone for out-of-hospital trauma analgesia: a randomized controlled trial. Ann Emerg Med. 2012 Jun;59(6):497-503. doi: 10.1016/j.annemergmed.2011.11.012. Epub 2012 Jan 13.

  PMID: 22243959 BACKGROUND

• Johansson P, Kongstad P, Johansson A. The effect of combined treatment with morphine sulphate and low-dose ketamine in a prehospital setting. Scand J Trauma Resusc Emerg Med. 2009 Nov 27;17:61. doi: 10.1186/1757-7241-17-61.

  PMID: 19943920 BACKGROUND

• Kissin I, Bright CA, Bradley EL Jr. The effect of ketamine on opioid-induced acute tolerance: can it explain reduction of opioid consumption with ketamine-opioid analgesic combinations? Anesth Analg. 2000 Dec;91(6):1483-8. doi: 10.1097/00000539-200012000-00035.

  PMID: 11094005 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Ketamine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This study was conducted in a busy ED in the general patient population, without special conditions, locations, or providers for study patients. The cohort includes subjects with chronic pain and long-term outpatient opioid use, as well as patients with new-onset acute pain; it is possible that the former patient population may react quite differently to the adjunctive ketamine usage than the latter.

Results Point of Contact

• Title: Dr Karen J Bowers, co-PI
• Organization: Virginia Tech SOM / Carilion Clinic (prior)

bowerskj@gmail.com

678-591-7280

Study Officials

• Corey R Heitz, MD

  Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 3, 2015
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 12, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-02