Primary Headaches (Includes Migraines, Tension, Cluster Headaches)NCT01406860
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches
A study testing Droperidol and Metoclopramide + diphenhydramine in people with Primary Headaches (Includes Migraines, Tension, Cluster Headaches), run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
- What is being tested?
- Droperidol and Metoclopramide + diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years old to 65 years old, diagnosis of primary headache
Who cannot join
- Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected
- ED Droperidol Protocol
- Droperidol must NOT be used in patients with any of the following:
- Known or suspected QT prolongation, including congenital long QT syndrome
- Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (< 50 bpm)]
- History of the following:
Show all 16Show fewer
- Renal failure
- Cerebrovascular disease
- Diabetes or hypoglycemia
- Alcoholism/alcohol abuse
- Pituitary insufficiency
- Hypothyroidism
- Hypothermia
- Anorexia
- Advanced age (>65 yrs)
- Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.
- Being tested
- Droperidol, Metoclopramide + diphenhydramine
- Keywords
- Headaches, Migraines, Tension headaches, Cluster headaches
- Medical subject headings
- Cluster Headache, Headache, Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroperidolDrug
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
Metoclopramide + diphenhydramineDrug
Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Droperidol | Experimental | Not described Receives: Drug: Droperidol |
| Metoclopramide + Diphenhydramine | Active comparator | Not described Receives: Drug: Metoclopramide + diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale (Numerical Rating Scale for Pain)
Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain
Measured: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Secondary outcomes (3)
Length of Stay
Measured: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)
24 Hour Pain Score
24 hour pain score (follow-up phone call)
Measured: 24 hours after discharge from ED
Adverse Effects
Frequency of adverse effects in each arm
Measured: From the time when the treatment is initiated until the 24 hour follow-up phone survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: lack of enrollment/drug shortages
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Headaches (Includes Migraines, Tension, Cluster Headaches)Studies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett A Faine, University of Iowa
- Investigators
- Jon Van Heukelom, MD, Principal investigator, University of IowaChristopher Hogrefe, MD, Principal investigator, University of IowaBrett Faine, PharmD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406860
- Sponsor's protocol ID
- 201008798
- Other IDs
- University of Iowa
- Status last verified
- Nov 2017
- First submitted
- 22 Sep 2010
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
- ClinicalTrials.gov ID
- NCT01406860
- Acronym / sponsor ID
- 201008798
- Keywords
- Headaches, Migraines, Tension headaches, Cluster headaches
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment/drug shortages
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Posted 5 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Droperidol | Experimental | Drug: Droperidol |
| Metoclopramide + Diphenhydramine | Active comparator | Drug: Metoclopramide + diphenhydramine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 years old to 65 years old, diagnosis of primary headache
Key exclusion criteria (16 listed)
- Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected
- ED Droperidol Protocol
- Known or suspected QT prolongation, including congenital long QT syndrome
- Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (< 50 bpm)]
- History of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DroperidolDroperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes | Drug | Droperidol |
| Metoclopramide + diphenhydramineMetoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion. | Drug | Metoclopramide + Diphenhydramine |
Primary outcome
Pain Scale (Numerical Rating Scale for Pain)
Time frame: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain
3 secondary outcomes
Length of Stay
Time frame: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)
24 Hour Pain Score
Time frame: 24 hours after discharge from ED
Adverse Effects
Time frame: From the time when the treatment is initiated until the 24 hour follow-up phone survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Van Heukelom, MD principal investigator
University of Iowa
Christopher Hogrefe, MD principal investigator
University of Iowa
Brett Faine, PharmD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Droperidol and Metoclopramide + diphenhydramine in people with Primary Headaches (Includes Migraines, Tension, Cluster Headaches), run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale (Numerical Rating Scale for Pain) (time frame: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.