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Ketamine v. Metoclopramide/Diphenhydramine for Acute Management of Migraine in the Emergency Department

This study is currently recruiting participants.
Verified July 2017 by Billy Sin, The Brooklyn Hospital Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03221569
First Posted: July 18, 2017
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Billy Sin, The Brooklyn Hospital Center
  Purpose

The study investigators are attempting to determine if ketamine can offer rapid, complete and sustained headache relief in the acute setting and 48 hrs post-discharge. The goal of this study is to enroll 40 patients total (20 per arm). 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. Each patient will receive an intranasal solution via atomizer and a 50 cc IV normal saline bag. Arm A would include 1 mg/kg intranasal ketamine and a 50 cc normal saline IV bag while Arm B would receive placebo intranasal dose and 10 mg Metroclopramide/25 mg Diphenahydramine mixed in 50 ccs normal saline. 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 30min, 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 Intervention Phase
Migraine Drug: Intranasal ketamine Drug: Diphenhydramine Drug: metoclopramide Drug: Normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Arm A would include 1 mg/kg intranasal ketamine and a 50 cc normal saline IV bag while Arm B would receive placebo intranasal dose and Metoclopramide 10mg/Diphenhydramine 25mg mixed in 50 ccs normal saline. For intranasal administration, the total volume of the dose will be administered in equivalent half volumes in each nare. For example, if the total dose equated to 1ml, the patient would receive 0.5ml in the left nare and 0.5ml in the right nare. A maximum dose of 1 ml will be given per nare. If the total dose exceeds 1 ml, this will be divided into two syringes, the volume above 1ml will be administered 2-3 minutes after administration of the initial volume.
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
Official Title: Ketamine v. Metoclopramide/Diphenhydramine for Acute Management of Migraine in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Billy Sin, The Brooklyn Hospital Center:

Primary Outcome Measures:
  • Pain scores [ Time Frame: At 30 minutes after initiation of study intervention ]
    10 point number rating scale


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: February 1, 2016
Estimated Study Completion Date: February 1, 2018
Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal ketamine

Arm will include 1 mg/kg intranasal ketamine for 1 dose and a 50ml normal saline intravenous (IV) bag for 1 dose during study period.

For intranasal administration, the total volume of the dose will be administered in equivalent half volumes in each nare. For example, if the total dose equated to 1ml, the patient would receive 0.5ml in the left nare and 0.5ml in the right nare. A maximum dose of 1 ml will be given per nare. If the total dose exceeds 1 ml, this will be divided into two syringes, the volume above 1ml will be administered 2-3 minutes after administration of the initial volume.

Drug: Intranasal ketamine
ketamine to be administered via intranasal atomizer.
Other Name: ketamine intranasal
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: metoclopramide and diphenhydramine
Arm will include Metoclopramide 10mg/Diphenhydramine 25mg mixed in 50 ml normal saline for one dose during study period. At the same time, patients in this arm will also receive intranasal normal saline for one dose during study period. For intranasal administration, the total volume of the dose will be administered in equivalent half volumes in each nare. For example, if the total dose equated to 1ml, the patient would receive 0.5ml in the left nare and 0.5ml in the right nare. A maximum dose of 1 ml will be given per nare. If the total dose exceeds 1 ml, this will be divided into two syringes, the volume above 1ml will be administered 2-3 minutes after administration of the initial volume.
Drug: Diphenhydramine
as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag
Other Name: benadyrl
Drug: metoclopramide
as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag
Other Name: reglan
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

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. Each patient will receive an intranasal solution via atomizer and a 50 cc IV normal saline bag. Once informed consent is obtained, patients would be enrolled in Arm A or Arm B depending upon the initial randomization. Arm A would include 1 mg/kg intranasal ketamine and a 50 cc normal saline IV bag while Arm B would receive placebo intranasal dose and Metoclopramide 10mg/Diphenhydramine 25mg mixed in 50 ccs normal saline. For intranasal administration, the total volume of the dose will be administered in equivalent half volumes in each nare. For example, if the total dose equated to 1ml, the patient would receive 0.5ml in the left nare and 0.5ml in the right nare. A maximum dose of 1 ml will be given per nare. If the total dose exceeds 1 ml, this will be divided into two syringes, the volume above 1ml will be administered 2-3 minutes after administration of the initial volume.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18-65 years old with an acute migraine or probable migraine based upon International Headache Society criteria,

Exclusion Criteria:

  • Non migraine primary headache disorder or unclassifiable
  • Previous enrollment in study, Patients with reported nasal congestion
  • Fever >100.3
  • Patients with suspected secondary headache disorder such as SAH or sinusitis,
  • Performance of lumbar puncture or potential need for lumbar puncture,
  • 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, diphenhydramine, metoclopramide,
  • Previous enrollment in the study
  • Patients with language barriers
  • Refusal to provide consent to receive intranasal or intravenous therapy
  • Reported illicit drug use within the past 5 days.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Billy Sin, PharmD 718-250-5000 ext 2450 bsin@tbh.org

Locations
United States, New York
The Brooklyn Hospital Center Recruiting
Brooklyn, New York, United States, 11201
Contact: Billy W Sin, Pharm.D.    718-250-6250      
Sponsors and Collaborators
The Brooklyn Hospital Center
  More Information

Responsible Party: Billy Sin, Director, Emergency Medicine Clinical Research Program, The Brooklyn Hospital Center
ClinicalTrials.gov Identifier: NCT03221569     History of Changes
Other Study ID Numbers: 779354-2
First Submitted: July 17, 2017
First Posted: July 18, 2017
Last Update Posted: July 19, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Emergencies
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketamine
Diphenhydramine
Metoclopramide
Promethazine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists


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