HeadachePhase 4I-FiBHNCT03185130
Intravenous Fluids in Benign Headaches Trial
A Phase 4 study testing Normal Saline 5mL, Normal Saline 20mL/kg and Prochlorperazine 0.15 mg/kg up to 10 mg IV in people with Headache, run by University Medical Center of Southern Nevada at 1 site in United States.
Trial summary
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- Normal Saline 5mL, Normal Saline 20mL/kg and Prochlorperazine 0.15 mg/kg up to 10 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 15 May 2019
- Phase
- Phase 4
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 10 to 65 years
- Temperature less than 100.4 F
- Normal neurologic exam and normal mental status
Who cannot join
- Pregnant
- Meningeal signs are present
- Acute angle closure glaucoma is suspected
- Head trauma within the previous two weeks
- Lumbar puncture within the previous two weeks
- Thunderclap onset of the headache
Show all 13Show fewer
- Known allergy to one of the study drugs
- History of intracranial hypertension
- Is a prisoner
- Patient declined informed consent
- Non-English speaking patient or parent/guardian for pediatric patients
- Attending provider excludes patient
- Severe Dehydration
Trial locations and contacts
1 site in 1 country.
United States1 site
University medical Center of Southern Nevada
Las Vegas, Nevada, 89102
About this study
Official title: Intravenous Fluids in Benign Headaches Trial: A Randomized Single Blind Clinical Trial
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.
Read the detailed description
This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a "rescue medication" of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.
- Conditions
- Headache
- Being tested
- Normal Saline 5mL, Normal Saline 20mL/kg, Prochlorperazine 0.15 mg/kg up to 10 mg IV, Diphenhydramine 1 mg/kg up to 50 mg IV
- Keywords
- Headache, Benign Headache
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline 5mLDrug
Also called NS, Saline
Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
Normal Saline 20mL/kgDrug
Also called NS, Saline
Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
Prochlorperazine 0.15 mg/kg up to 10 mg IVDrug
Also called Compazine
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Diphenhydramine 1 mg/kg up to 50 mg IVDrug
Also called Benadryl
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Arm | Active comparator | Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Receives: Drug: Normal Saline 5mL; Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV; Drug: Diphenhydramine 1 mg/kg up to 50 mg IV |
| Study Arm | Experimental | Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Receives: Drug: Normal Saline 20mL/kg; Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV; Drug: Diphenhydramine 1 mg/kg up to 50 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Pain Scores at 60 Minutes
The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.
Measured: 60 minutes
Secondary outcomes (6)
Reduction in Pain Score at 30 Minutes
The mean reduction in pain scores at 30 minutes. This is calculated as the pain score at time zero minus the pain score at time 30 minutes. Pain scores are measured 0-100 on a visual analog scale score, with 0 being no pain and 100 being maximal pain. Higher numbers indicate more pain reduction.
Measured: 30 minutes
Admissions
The difference between the rates of admission will be measured.
Measured: 1 day
Reduction in Nausea Score at 60 Minutes
The reduction in mean nausea scores will be measured. This is calculated as the nausea score at time zero minus the nausea score at time 60 minutes. Nausea is measured from 0-100 on a visual analog scale with 0 being no nausea and 100 being maximal nausea. Higher numbers indicate more reduction in nausea.
Measured: 60 minutes
Vomiting
The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.
Measured: 60 minutes
Rescue Medication
The difference between the percentage of patients requiring rescue medications for headache will be measured. "Rescue medications" are defined as any medication administered to the patient in the emergency department for their headache after the initial medications.
Measured: 60 minutes
Percentage of Patients With Persistent Headache
The difference between the rates of persistent headache with telephone follow up.
Measured: 24-48 hours after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start16 May 2017
- Primary completion15 May 2019
- Study completion15 May 2019
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.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center of Southern Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph (Tony) Zitek, MD, University Medical Center of Southern Nevada
- Investigators
- Tony Zitek, MD, Principal investigator, University Medical Center of Southern Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185130
- Sponsor's protocol ID
- 2017-54
- Acronym
- I-FiBH
- Status last verified
- May 2024
- First submitted
- 10 Jun 2017
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be shared.
Publications
Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
PubMed 17261680Friedman BW, West J, Vinson DR, Minen MT, Restivo A, Gallagher EJ. Current management of migraine in US emergency departments: an analysis of the National Hospital Ambulatory Medical Care Survey. Cephalalgia. 2015 Apr;35(4):301-9. doi: 10.1177/0333102414539055. Epub 2014 Jun 19.
PubMed 24948146Balbin JE, Nerenberg R, Baratloo A, Friedman BW. Intravenous fluids for migraine: a post hoc analysis of clinical trial data. Am J Emerg Med. 2016 Apr;34(4):713-6. doi: 10.1016/j.ajem.2015.12.080. Epub 2015 Dec 30.
PubMed 26825817Cicek M, Karcioglu O, Parlak I, Ozturk V, Duman O, Serinken M, Guryay M. Prospective, randomised, double blind, controlled comparison of metoclopramide and pethidine in the emergency treatment of acute primary vascular and tension type headache episodes. Emerg Med J. 2004 May;21(3):323-6. doi: 10.1136/emj.2002.000356.
PubMed 15107371Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.
PubMed 23567060Kostic MA, Gutierrez FJ, Rieg TS, Moore TS, Gendron RT. A prospective, randomized trial of intravenous prochlorperazine versus subcutaneous sumatriptan in acute migraine therapy in the emergency department. Ann Emerg Med. 2010 Jul;56(1):1-6. doi: 10.1016/j.annemergmed.2009.11.020. Epub 2010 Jan 4.
PubMed 20045576Tanen DA, Miller S, French T, Riffenburgh RH. Intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headaches: a prospective, randomized, double-blind trial. Ann Emerg Med. 2003 Jun;41(6):847-53. doi: 10.1067/mem.2003.195.
PubMed 12764341Jones J, Sklar D, Dougherty J, White W. Randomized double-blind trial of intravenous prochlorperazine for the treatment of acute headache. JAMA. 1989 Feb 24;261(8):1174-6.
PubMed 2915441Friedman BW, Esses D, Solorzano C, Dua N, Greenwald P, Radulescu R, Chang E, Hochberg M, Campbell C, Aghera A, Valentin T, Paternoster J, Bijur P, Lipton RB, Gallagher EJ. A randomized controlled trial of prochlorperazine versus metoclopramide for treatment of acute migraine. Ann Emerg Med. 2008 Oct;52(4):399-406. doi: 10.1016/j.annemergmed.2007.09.027. Epub 2007 Nov 19.
PubMed 18006188Callan JE, Kostic MA, Bachrach EA, Rieg TS. Prochlorperazine vs. promethazine for headache treatment in the emergency department: a randomized controlled trial. J Emerg Med. 2008 Oct;35(3):247-53. doi: 10.1016/j.jemermed.2007.09.047. Epub 2008 Jun 5.
PubMed 18534808Coppola M, Yealy DM, Leibold RA. Randomized, placebo-controlled evaluation of prochlorperazine versus metoclopramide for emergency department treatment of migraine headache. Ann Emerg Med. 1995 Nov;26(5):541-6. doi: 10.1016/s0196-0644(95)70001-3.
PubMed 7486359Miner JR, Fish SJ, Smith SW, Biros MH. Droperidol vs. prochlorperazine for benign headaches in the emergency department. Acad Emerg Med. 2001 Sep;8(9):873-9. doi: 10.1111/j.1553-2712.2001.tb01147.x.
PubMed 11535479Dychter SS, Gold DA, Carson D, Haller M. Intravenous therapy: a review of complications and economic considerations of peripheral access. J Infus Nurs. 2012 Mar-Apr;35(2):84-91. doi: 10.1097/NAN.0b013e31824237ce.
PubMed 22382792Homer LD, Holmes KR. Risks associated with 72- and 96-hour peripheral intravenous catheter dwell times. J Intraven Nurs. 1998 Sep-Oct;21(5):301-5.
PubMed 9814284Gentges J, Arthur A, Stamile T, Figureido M. Peripheral Intravenous Line Placement and Utilization in an Academic Emergency Department. J Emerg Med. 2016 Feb;50(2):235-8. doi: 10.1016/j.jemermed.2015.08.006.
PubMed 26433429
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluids in Benign Headaches Trial: A Randomized Single Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03185130
- Acronym / sponsor ID
- I-FiBH / 2017-54
- Conditions
- Headache
- Keywords
- Headache, Benign Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Medical Center of Southern NevadaUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.
Detailed description
This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a "rescue medication" of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache.
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Arm | Active comparator | Drug: Normal Saline 5mL, Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV, Drug: Diphenhydramine 1 mg/kg up to 50 mg IVStandard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. |
| Study Arm | Experimental | Drug: Normal Saline 20mL/kg, Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV, Drug: Diphenhydramine 1 mg/kg up to 50 mg IVStudy arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 10 to 65 years
- Temperature less than 100.4 F
- Normal neurologic exam and normal mental status
Key exclusion criteria (13 listed)
- Pregnant
- Meningeal signs are present
- Acute angle closure glaucoma is suspected
- Head trauma within the previous two weeks
- Lumbar puncture within the previous two weeks
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 |
|---|---|---|
| Normal Saline 5mLAlso: NS, SalineControl arm subjects will receive Normal Saline 5 mL IV over 1 hour | Drug | Standard Treatment Arm |
| Normal Saline 20mL/kgAlso: NS, SalineStudy arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, | Drug | Study Arm |
| Prochlorperazine 0.15 mg/kg up to 10 mg IVAlso: CompazineStandard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push | Drug | Standard Treatment Arm, Study Arm |
| Diphenhydramine 1 mg/kg up to 50 mg IVAlso: BenadrylDiphenhydramine dose 1 mg/kg up to 50 mg IV slow push | Drug | Standard Treatment Arm, Study Arm |
Primary outcome
Reduction in Pain Scores at 60 Minutes
Time frame: 60 minutes
The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.
6 secondary outcomes
Reduction in Pain Score at 30 Minutes
Time frame: 30 minutes
Admissions
Time frame: 1 day
Reduction in Nausea Score at 60 Minutes
Time frame: 60 minutes
Vomiting
Time frame: 60 minutes
Rescue Medication
Time frame: 60 minutes
Percentage of Patients With Persistent Headache
Time frame: 24-48 hours after discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17261680Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
- Background: PubMed 24948146Friedman BW, West J, Vinson DR, Minen MT, Restivo A, Gallagher EJ. Current management of migraine in US emergency departments: an analysis of the National Hospital Ambulatory Medical Care Survey. Cephalalgia. 2015 Apr;35(4):301-9. doi: 10.1177/0333102414539055. Epub 2014 Jun 19.
- Background: PubMed 26825817Balbin JE, Nerenberg R, Baratloo A, Friedman BW. Intravenous fluids for migraine: a post hoc analysis of clinical trial data. Am J Emerg Med. 2016 Apr;34(4):713-6. doi: 10.1016/j.ajem.2015.12.080. Epub 2015 Dec 30.
- Background: PubMed 15107371Cicek M, Karcioglu O, Parlak I, Ozturk V, Duman O, Serinken M, Guryay M. Prospective, randomised, double blind, controlled comparison of metoclopramide and pethidine in the emergency treatment of acute primary vascular and tension type headache episodes. Emerg Med J. 2004 May;21(3):323-6. doi: 10.1136/emj.2002.000356.
- Background: PubMed 23567060Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.
- Background: PubMed 20045576Kostic MA, Gutierrez FJ, Rieg TS, Moore TS, Gendron RT. A prospective, randomized trial of intravenous prochlorperazine versus subcutaneous sumatriptan in acute migraine therapy in the emergency department. Ann Emerg Med. 2010 Jul;56(1):1-6. doi: 10.1016/j.annemergmed.2009.11.020. Epub 2010 Jan 4.
- Background: PubMed 12764341Tanen DA, Miller S, French T, Riffenburgh RH. Intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headaches: a prospective, randomized, double-blind trial. Ann Emerg Med. 2003 Jun;41(6):847-53. doi: 10.1067/mem.2003.195.
- Background: PubMed 2915441Jones J, Sklar D, Dougherty J, White W. Randomized double-blind trial of intravenous prochlorperazine for the treatment of acute headache. JAMA. 1989 Feb 24;261(8):1174-6.
- Background: PubMed 18006188Friedman BW, Esses D, Solorzano C, Dua N, Greenwald P, Radulescu R, Chang E, Hochberg M, Campbell C, Aghera A, Valentin T, Paternoster J, Bijur P, Lipton RB, Gallagher EJ. A randomized controlled trial of prochlorperazine versus metoclopramide for treatment of acute migraine. Ann Emerg Med. 2008 Oct;52(4):399-406. doi: 10.1016/j.annemergmed.2007.09.027. Epub 2007 Nov 19.
- Background: PubMed 18534808Callan JE, Kostic MA, Bachrach EA, Rieg TS. Prochlorperazine vs. promethazine for headache treatment in the emergency department: a randomized controlled trial. J Emerg Med. 2008 Oct;35(3):247-53. doi: 10.1016/j.jemermed.2007.09.047. Epub 2008 Jun 5.
- Background: PubMed 7486359Coppola M, Yealy DM, Leibold RA. Randomized, placebo-controlled evaluation of prochlorperazine versus metoclopramide for emergency department treatment of migraine headache. Ann Emerg Med. 1995 Nov;26(5):541-6. doi: 10.1016/s0196-0644(95)70001-3.
- Background: PubMed 11535479Miner JR, Fish SJ, Smith SW, Biros MH. Droperidol vs. prochlorperazine for benign headaches in the emergency department. Acad Emerg Med. 2001 Sep;8(9):873-9. doi: 10.1111/j.1553-2712.2001.tb01147.x.
- Individual participant dataSharing planned: No. IPD data will not be shared.
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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.
Tony Zitek, MD principal investigator
University Medical Center of Southern Nevada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline 5mL, Normal Saline 20mL/kg and Prochlorperazine 0.15 mg/kg up to 10 mg IV in people with Headache, run by University Medical Center of Southern Nevada 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 6 Jun 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). 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?
Reduction in Pain Scores at 60 Minutes (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185130, which also lists 21 linked publications.
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 6 Jun 2024.