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Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

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ClinicalTrials.gov Identifier: NCT03221569
Recruitment Status : Unknown
Verified July 2018 by Billy Sin, The Brooklyn Hospital Center.
Recruitment status was:  Recruiting
First Posted : July 18, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Billy Sin, The Brooklyn Hospital Center

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE February 1, 2016
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
Pain scores [ Time Frame: At 30 minutes after initiation of study intervention ]
10 point number rating scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • Incidence of adverse events [ Time Frame: throughout study period (105 mins) ]
    adverse events reported in each group
  • mean dose of rescue analgesia required [ Time Frame: throughout study period (105 minutess) ]
    dose of rescue analgesia required in each group
  • length of stay [ Time Frame: throughout study period (105 minutes) ]
    median ED length of stay in each group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine v. Ketorolac for Management of Generalized Tension Type Headache
Official Title  ICMJE Ketamine v. Ketorolac for Management of Generalized Tension Type Headache
Brief Summary

The hypothesis of the study is that sub-dissociative dose ketamine will prove to be superior to or as standard therapy, ketorolac, in the treatment of acute tension type headache (TTH) as measured by the 10 point Numerical Rating Scale (NRS. The aim of the study is to compare the safety & efficacy of intravenous sub-dissociative dose ketamine versus ketorolac for acute treatment of migraines in the Emergency Department (ED) The primary endpoints are: Patient perception of pain as described by the use the Numerical Rating Scale (NRS) at 30 minutes.

The secondary endpoints are: Frequency and mean dose of rescue/additional doses of therapy at 15, 30, 45, 60, 75, 90 min, Number of emergency department re-visits for acute migraine one month post discharge, incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams) during study period, incidence of nausea, vomiting, or worsening headache, Incidence of bad taste, Incidence of burning sensations in the nostrils, incidence of hypertension, time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale.

Detailed Description

This will be a "double-dummy" study in that there will be no placebo only arm. Medications will be administered in a double blind randomized fashion. Patients would be enrolled in Arm A or Arm B depending upon the initial randomization. Arm A would include 0.3 mg/kg ketamine into a 100 cc normal saline IV bag and normal saline injection (1ml) while Arm B would receive 100cc of normal saline and 30mg of ketorolac intravenously.

An order would be placed by the medical resident, medical attending, a study investigator who is a physician, or a pharmacist under the permission of the attending physician into Allscripts for a study intervention. Upon receiving the order in Allscripts, the order would be verified by the pharmacy. All medications will be prepared in pharmacy, which will maintain a master list of contents of each sealed envelope. Once notified of which envelope has been pulled, the pharmacist will prepare either arm. ED personnel will obtain the infusion preparation from pharmacy. It will be labeled for the patient, with study number, but without other identifying marks. When the study medication is picked up, pharmacy will open the sealed envelope to confirm which medication arm was prepared in order to internally verify the correct preparation. The nurse assigned to the patient would administer the intervention. A research associate or a study investigator would approach the patient to assess and record primary outcomes, secondary outcomes at designed time intervals. The data will be recorded on the data collection instrument. If additional medication is requested by the patient, the orders would be placed by the medical resident or attending who are assigned to the patient in the ED. Upon completion of the treatment portion of the study, patients will be asked of the participant's satisfaction with therapy. Only the patient who signed the consent form will be allowed to answer the questions.

All data retrieved from the paper data collection sheets will be transcribed into an encrypted and password protected electronic database by the research associate. All patient identifiers would be de-identified in the database. All participants would be assigned a study participant number.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Arm A would include 0.3mg/kg intravenous piggyback ketamine and 1cc normal saline as placebo via intravenous push while Arm B would receive 50ml normal saline and ketorolac 30mg.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Aside from primary investigator (B.Sin) and pharmacist procuring the study interventions, blinding will be applied to patient, physicians, nurses, research associates responsible for collect data and also the independent biostatistician responsible for evaluating the data. Patients will be randomized to receive study numbers that corresponds to treatment arms.
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Intravenous ketamine
    0.3mg/kg IVPB over 15 minutes
    Other Name: ketamine intravenous
  • Drug: Ketorolac
    as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag
  • Drug: Normal saline

    Will be given as 50ml intravenous bag as placebo for double-blinding purposes in patients who will also receive intranasal ketamine.

    Will be prepared in intranasal syringe for double blinding purposes for patients who are randomized to receive intranasal ketamine.

    Other Name: saline
  • Drug: Normal saline
    1ml intravenous push as placebo for double-blinding purposes
    Other Name: saline
Study Arms  ICMJE
  • Experimental: Intravenous ketamine
    Arm will include 0.3 mg/kg intravenous piggyback ketamine over 10 minutes for 1 dose and a 1ml normal saline placebo via intravenous push
    Interventions:
    • Drug: Intravenous ketamine
    • Drug: Normal saline
  • Active Comparator: ketorolac
    Arm will include 30mg ketorolac intravenous push and 50ml normal saline over 10 minutes
    Interventions:
    • Drug: Ketorolac
    • Drug: Normal saline
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 5, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2017)
40
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The inclusion criteria are: Patients 18-65 years old who provides informed consent and presents to the ED with an acute tension type headache (TTH), as classified by meeting the following:

    1. Have at least 10 episodes of headache occurring on average less than 12 days per year AND Fullfuling B-D B. Lasting 30mins to 7 days C. At least 2 of the following 4 criteria
    1. bilateral location
    2. pressing/tightening (non-pulsating)
    3. mild or moderate
    4. not aggravated by routine physical activity such as walking or climbing stairs D. Both of the following
    1. no nausea/vomiting
    2. No more than one of photophobia or phonophobia

Exclusion Criteria: Non migraine primary headache disorder or unclassifiable, previous enrollment in study, fever >100.3, Patients with suspected secondary headache disorder such as SAH or sinusitis, performance of lumbar puncture or potential need for LP, Severe hypertension (≥180/100), History of CAD or hypertension, presence of/suspected for traumatic head injury in the past 30 days with or without loss of consciousness, Presence of/suspected for myocardial ischemia, presence of/suspected for alcohol intoxication, Hemodynamic instability, history of psychiatric disorders, known or suspected pregnancy or breast feeding, allergy to ketamine, ketorolac, previous enrollment in the study, patients with language barriers, refusal to provide consent to receive intravenous therapy, reported illicit drug use within the past 5 days, patients weighing over 100kg

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221569
Other Study ID Numbers  ICMJE 779354-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Billy Sin, The Brooklyn Hospital Center
Study Sponsor  ICMJE The Brooklyn Hospital Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Brooklyn Hospital Center
Verification Date July 2018

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