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

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ClinicalTrials.gov Identifier: NCT02489630
Recruitment Status : Completed
First Posted : July 3, 2015
Results First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Collaborators:
Virginia Polytechnic Institute and State University
University of Memphis
Information provided by (Responsible Party):
Carilion Clinic

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 3, 2015
Results First Submitted Date  ICMJE February 10, 2020
Results First Posted Date  ICMJE March 12, 2021
Last Update Posted Date March 12, 2021
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2021)
  • Change in Level of Pain Control as Reported on the NRS-11 [ Time Frame: 20 min pre-medication administration, 0 min, 30 min, 60 min, 90 min, 120 min post medication administration ]
    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).
  • Change in Patient Satisfaction With Pain Control on a 1-4 Likert Scale [ Time Frame: 0 min, 30 min, 60 min, 90 min, 120 min post medication administration ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
  • Change in level of pain control as reported on the NRS-11 [ Time Frame: 0 min, 30 min, 60 min, 90 min, 120 min ]
    Patient-reported pain scores on NRS-11 pain scale
  • Change in patient satisfaction with pain control on a 1-4 Likert Scale [ Time Frame: 0 min, 30 min, 60 min, 90 min, 120 min ]
    Patient-reported score regarding satisfaction with pain control, reported on a 4-point Likert scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2021)
Difference in Opiate Dosage Between Study Arms in Morphine Equivalents [ Time Frame: 20 mins pre-medication administration, 0 min, 30 min, 60 min, 90 min, 120 min post medication administration ]
Average difference in opiate dosage between study arms, calculated in morphine equivalents. "Initial" indicates at first dose of opioid administration, up to 20 mins prior to study drug administration, and from 0 min to 120 min after study drug administration.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
Difference in opiate dosage between study arms in morphine equivalents [ Time Frame: 0 min, 30 min, 60 min, 90 min, 120 min ]
Average difference in opiate dosage between study arms, calculated in morphine equivalents
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
Official Title  ICMJE Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
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.
Detailed Description

This randomized, double blinded, placebo controlled study investigates the use of low-dose ketamine, in conjunction to standard opiate treatment, as compared to placebo plus standard opiate treatment, for acute painful conditions in the ED setting. The investigators hypothesize that patients treated with ketamine will require less opiate for similar levels of pain relief up to 2 hours from initiation of treatment, with similar levels of patient satisfaction and an acceptable side effect profile.

Once seen by a physician, potential patients will receive provider-determined opiate treatment for their painful condition, prior to the informed consent process to ensure that treatment is not delayed. Once identified for inclusion, patients will receive informed consent and, upon consent, will subsequently be randomized through block randomization into one of two study groups. Each study group will contain at least 50 subjects. Randomization will be determined using a table of random numbers, using a restricted randomization scheme to ensure roughly equal numbers in each group. Group assignments will be sealed in opaque envelopes to be opened sequentially by the investigators. Group assignments will not indicate whether it is the treatment or the control group. At this time (T0), an initial NRS-11 score will be obtained. The NRS-11 is an 11-point scale on which patients rate their level of pain from 0 ("no pain") to 10 ("worst pain imaginable"). If, after initial analgesic, pain level is <6, patients will be asked again in 15 min. If at this time it is still <6, they will not proceed in the study. The intervention group will receive 0.1 mg/kg of ketamine given over 1 minute, and the control group will receive an equivalent volume of normal saline; both groups will have received a provider-determined dose of opiate analgesia prior to enrollment. At thirty-minute intervals, subjects will be asked their level of pain, if they need more pain control and will be evaluated for the presence of side effects (hallucinations, dysphoria, weakness, diplopia, nausea, vomiting, dizziness, itching and bradypnea) as well as sedation as defined by Ramsay score of greater than 2. Repeat doses of pain medication will be given as 0.05 mg/kg morphine or equivalent dose of opioid analgesic. Total opiate dosage and number of repeat doses given at the end of 120 minutes will be recorded. At each time interval, as well as at the end of 120 minutes (T120), patient satisfaction with pain control will be recoded on the 4-point Likert scale, with 0 being "completely unsatisfied" and 3 being "very satisfied".

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain
  • Pain
Intervention  ICMJE
  • Drug: Ketamine
    0.1mg/kg ketamine IV
    Other Name: Ketalar
  • Drug: Normal Saline
    1ml/kg normal saline placebo
    Other Name: NS, saline
  • Drug: opiate analgesic
    0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request
Study Arms  ICMJE
  • Experimental: Ketamine
    0.1 mg/kg ketamine + opiate analgesic
    Interventions:
    • Drug: Ketamine
    • Drug: opiate analgesic
  • Placebo Comparator: Placebo
    0.1 mL/kg normal saline + opiate analgesic
    Interventions:
    • Drug: Normal Saline
    • Drug: opiate analgesic
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2015)
116
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489630
Other Study ID Numbers  ICMJE 08302015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carilion Clinic
Study Sponsor  ICMJE Carilion Clinic
Collaborators  ICMJE
  • Virginia Polytechnic Institute and State University
  • University of Memphis
Investigators  ICMJE
Principal Investigator: Corey R Heitz, MD Physician
PRS Account Carilion Clinic
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP