search
Back to results

Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

Primary Purpose

Migraine

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous ketamine
Ketorolac
Normal saline
Normal saline
Sponsored by
The Brooklyn Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Brooklyn Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravenous ketamine

ketorolac

Arm Description

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

Arm will include 30mg ketorolac intravenous push and 50ml normal saline over 10 minutes

Outcomes

Primary Outcome Measures

Pain scores
10 point number rating scale

Secondary Outcome Measures

Incidence of adverse events
adverse events reported in each group
mean dose of rescue analgesia required
dose of rescue analgesia required in each group
length of stay
median ED length of stay in each group

Full Information

First Posted
July 17, 2017
Last Updated
July 5, 2018
Sponsor
The Brooklyn Hospital Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03221569
Brief Title
Ketamine v. Ketorolac for Management of Generalized Tension Type Headache
Official Title
Ketamine v. Ketorolac for Management of Generalized Tension Type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Brooklyn Hospital Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous ketamine
Arm Type
Experimental
Arm Description
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
Arm Title
ketorolac
Arm Type
Active Comparator
Arm Description
Arm will include 30mg ketorolac intravenous push and 50ml normal saline over 10 minutes
Intervention Type
Drug
Intervention Name(s)
Intravenous ketamine
Other Intervention Name(s)
ketamine intravenous
Intervention Description
0.3mg/kg IVPB over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
saline
Intervention Description
1ml intravenous push as placebo for double-blinding purposes
Primary Outcome Measure Information:
Title
Pain scores
Description
10 point number rating scale
Time Frame
At 30 minutes after initiation of study intervention
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
adverse events reported in each group
Time Frame
throughout study period (105 mins)
Title
mean dose of rescue analgesia required
Description
dose of rescue analgesia required in each group
Time Frame
throughout study period (105 minutess)
Title
length of stay
Description
median ED length of stay in each group
Time Frame
throughout study period (105 minutes)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 bilateral location pressing/tightening (non-pulsating) mild or moderate not aggravated by routine physical activity such as walking or climbing stairs D. Both of the following no nausea/vomiting 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Billy Sin, PharmD
Phone
718-250-5000
Ext
2450
Email
bsin@tbh.org
Facility Information:
Facility Name
The Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Billy W Sin, Pharm.D.
Phone
718-250-6250

12. IPD Sharing Statement

Learn more about this trial

Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

We'll reach out to this number within 24 hrs