Ketamine v. Ketorolac for Management of Generalized Tension Type Headache
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|ClinicalTrials.gov Identifier: NCT03221569|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : July 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Intravenous ketamine Drug: Ketorolac Drug: Normal saline||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|Official Title:||Ketamine v. Ketorolac for Management of Generalized Tension Type Headache|
|Actual Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2020|
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
Drug: Intravenous ketamine
0.3mg/kg IVPB over 15 minutes
Other Name: ketamine intravenous
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
Active Comparator: ketorolac
Arm will include 30mg ketorolac intravenous push and 50ml normal saline over 10 minutes
as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag
Drug: Normal saline
1ml intravenous push as placebo for double-blinding purposes
Other Name: saline
- Pain scores [ Time Frame: At 30 minutes after initiation of study intervention ]10 point number rating scale
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221569
|Contact: Billy Sin, PharmD||718-250-5000 ext email@example.com|
|United States, New York|
|The Brooklyn Hospital Center||Recruiting|
|Brooklyn, New York, United States, 11201|
|Contact: Billy W Sin, Pharm.D. 718-250-6250|