Ketamine v. Ketorolac for Management of Generalized Tension Type Headache

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.

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