MigrainePhase 4NCT01534806
Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department
A Phase 4 study testing Ketorolac in people with Migraine, run by Akron Children's Hospital at 1 site in United States.
Trial summary
The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in combination lead in a larger reduction in pain score compared to prochlorperazine alone when treating pediatric migraine in the Emergency Department (ED). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Migraine
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache
- patient has an established diagnosis of migraine without aura or as established by history meets the criteria for migraine headache as defined by the International Criteria for Headache Disorder -II in 2004 a. At least 5 episodes of headache b. The headache should last between 1-72 hours c. The headache should include two of the following: i. Unilateral location, though may be bifrontal or frontotemporal in location but should not be occipital ii. Pulsing quality iii. Moderate to severe pain iv. Aggravation by or causing avoidance of routine physical activity d. One of the following symptoms should accompany the headache i. Nausea or vomiting ii. Photophobia or phonophobia e. The headache should not be attributed to another disorder based on history, physical and/or laboratory information.
Who cannot join
- Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen
- Patients unable to complete the pain scale.
- Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen.
- Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma
- Female patients with a positive urine HCG point of care test
- Patients with diagnosis of or suspected to have chronic daily headaches defined as a headache lasting at least 4 hours for more than 15 days a month for the past 3 months.
- Patients who received prochlorperazine or ketorolac in the past 48 hours.
- Patients who had previously been randomized in this study in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blinded Study Comparing Use of Prochlorperazine Versus Prochlorperazine and Ketorolac in the Treatment of Pediatric Migraine in the Emergency Department
The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in combination lead in a larger reduction in pain score compared to prochlorperazine alone when treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this combination of medications treats not only the pain but also the associated gastrointestinal symptoms of migraine. The main outcome of this study is the reduction in the patient's pain score at 60 minutes from administration of the study medications. Secondary outcomes include the number of patients achieving complete resolution of the headache while in the ED, the number of patients requiring additional treatment interventions by the treating physician, the number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge, and side effects of the medications.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Ketorolac(0.5mg/kg) IV push
PlaceboDrug
Sodium Chloride 0.9% - 10 mL IV push
| Study group | Role | What they receive |
|---|---|---|
| ketorolac | Experimental | Not described Receives: Drug: Ketorolac |
| Placebo | Placebo comparator | Placebo IV push Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the patient's pain score at 60 minutes from administration of the study medications
Measured: 60 minutes from administration of the study medications
Secondary outcomes (5)
number of patients achieving complete resolution of the headache while in the emergency department.
Measured: while in the emergency department, an expected average of 2 hours.
number of patients requiring additional treatment interventions by the treating physician
Measured: while in the emergency department, an expected average of 2 hours.
number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia
Measured: while in the emergency department, an expected average of 2 hours.
recurrence of headache
Measured: 48-72 hours after discharge
side effects of medications
Measured: 48-72 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 posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2012
Why it stopped: Drug is backordered;
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sarah Kline-Krammes, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534806
- Sponsor's protocol ID
- 110808
- Status last verified
- Jun 2014
- First submitted
- 8 Nov 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kan L, Nagelberg J, Maytal J. Headaches in a pediatric emergency department: etiology, imaging, and treatment. Headache. 2000 Jan;40(1):25-9. doi: 10.1046/j.1526-4610.2000.00004.x.
PubMed 10759899Lewis DW, Qureshi F. Acute headache in children and adolescents presenting to the emergency department. Headache. 2000 Mar;40(3):200-3. doi: 10.1046/j.1526-4610.2000.00029.x.
PubMed 10759922Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):646-57. doi: 10.1046/j.1526-4610.2001.041007646.x.
PubMed 11554952Lewis DW. Toward the definition of childhood migraine. Curr Opin Pediatr. 2004 Dec;16(6):628-36. doi: 10.1097/01.mop.0000143763.17125.03.
PubMed 15548924Hamalainen ML, Hoppu K, Valkeila E, Santavuori P. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a double-blind, randomized, placebo-controlled, crossover study. Neurology. 1997 Jan;48(1):103-7. doi: 10.1212/wnl.48.1.103.
PubMed 9008503Jones 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 2915441Coppola 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 7486359Seim MB, March JA, Dunn KA. Intravenous ketorolac vs intravenous prochlorperazine for the treatment of migraine headaches. Acad Emerg Med. 1998 Jun;5(6):573-6. doi: 10.1111/j.1553-2712.1998.tb02463.x.
PubMed 9660282Kabbouche MA, Vockell AL, LeCates SL, Powers SW, Hershey AD. Tolerability and effectiveness of prochlorperazine for intractable migraine in children. Pediatrics. 2001 Apr;107(4):E62. doi: 10.1542/peds.107.4.e62.
PubMed 11335783Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9.
PubMed 14747817Trottier ED, Bailey B, Dauphin-Pierre S, Gravel J. Clinical outcomes of children treated with intravenous prochlorperazine for migraine in a pediatric emergency department. J Emerg Med. 2010 Aug;39(2):166-73. doi: 10.1016/j.jemermed.2008.08.012. Epub 2009 Jan 15.
PubMed 19150192Trottier ED, Bailey B, Lucas N, Lortie A. Prochlorperazine in children with migraine: a look at its effectiveness and rate of akathisia. Am J Emerg Med. 2012 Mar;30(3):456-63. doi: 10.1016/j.ajem.2010.12.020. Epub 2011 Feb 5.
PubMed 21296523McGrath PA. The multidimensional assessment and management of recurrent pain syndromes in children. Behav Res Ther. 1987;25(4):251-62. doi: 10.1016/0005-7967(87)90003-9. No abstract available.
PubMed 3662987Chambers CT, Giesbrecht K, Craig KD, Bennett SM, Huntsman E. A comparison of faces scales for the measurement of pediatric pain: children's and parents' ratings. Pain. 1999 Oct;83(1):25-35. doi: 10.1016/s0304-3959(99)00086-x.
PubMed 10506669
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Study Comparing Use of Prochlorperazine Versus Prochlorperazine and Ketorolac in the Treatment of Pediatric Migraine in the Emergency Department
- ClinicalTrials.gov ID
- NCT01534806
- Acronym / sponsor ID
- 110808
- Conditions
- Migraine
- Keywords
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug is backordered;
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in combination lead in a larger reduction in pain score compared to prochlorperazine alone when treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this combination of medications treats not only the pain but also the associated gastrointestinal symptoms of migraine. The main outcome of this study is the reduction in the patient's pain score at 60 minutes from administration of the study medications. Secondary outcomes include the number of patients achieving complete resolution of the headache while in the ED, the number of patients requiring additional treatment interventions by the treating physician, the number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge, and side effects of the medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketorolac | Experimental | Drug: Ketorolac |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo IV push |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache
- patient has an established diagnosis of migraine without aura or as established by history meets the criteria for migraine headache as defined by the International Criteria for Headache Disorder -II in 2004 a. At least 5 episodes of headache b. The headache should last between 1-72 hours c. The headache should include two of the following: i. Unilateral location, though may be bifrontal or frontotemporal in location but should not be occipital ii. Pulsing quality iii. Moderate to severe pain iv. Aggravation by or causing avoidance of routine physical activity d. One of the following symptoms should accompany the headache i. Nausea or vomiting ii. Photophobia or phonophobia e. The headache should not be attributed to another disorder based on history, physical and/or laboratory information.
Key exclusion criteria (8 listed)
- Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen
- Patients unable to complete the pain scale.
- Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen.
- Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma
- Female patients with a positive urine HCG point of care test
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 |
|---|---|---|
| KetorolacKetorolac(0.5mg/kg) IV push | Drug | ketorolac |
| PlaceboSodium Chloride 0.9% - 10 mL IV push | Drug | Placebo |
Primary outcome
Reduction in the patient's pain score at 60 minutes from administration of the study medications
Time frame: 60 minutes from administration of the study medications
5 secondary outcomes
number of patients achieving complete resolution of the headache while in the emergency department.
Time frame: while in the emergency department, an expected average of 2 hours.
number of patients requiring additional treatment interventions by the treating physician
Time frame: while in the emergency department, an expected average of 2 hours.
number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia
Time frame: while in the emergency department, an expected average of 2 hours.
recurrence of headache
Time frame: 48-72 hours after discharge
side effects of medications
Time frame: 48-72 hours after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Background: PubMed 10759899Kan L, Nagelberg J, Maytal J. Headaches in a pediatric emergency department: etiology, imaging, and treatment. Headache. 2000 Jan;40(1):25-9. doi: 10.1046/j.1526-4610.2000.00004.x.
- Background: PubMed 10759922Lewis DW, Qureshi F. Acute headache in children and adolescents presenting to the emergency department. Headache. 2000 Mar;40(3):200-3. doi: 10.1046/j.1526-4610.2000.00029.x.
- Background: PubMed 11554952Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):646-57. doi: 10.1046/j.1526-4610.2001.041007646.x.
- Background: PubMed 15548924Lewis DW. Toward the definition of childhood migraine. Curr Opin Pediatr. 2004 Dec;16(6):628-36. doi: 10.1097/01.mop.0000143763.17125.03.
- Background: PubMed 9008503Hamalainen ML, Hoppu K, Valkeila E, Santavuori P. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a double-blind, randomized, placebo-controlled, crossover study. Neurology. 1997 Jan;48(1):103-7. doi: 10.1212/wnl.48.1.103.
- 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 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 9660282Seim MB, March JA, Dunn KA. Intravenous ketorolac vs intravenous prochlorperazine for the treatment of migraine headaches. Acad Emerg Med. 1998 Jun;5(6):573-6. doi: 10.1111/j.1553-2712.1998.tb02463.x.
- Background: PubMed 11335783Kabbouche MA, Vockell AL, LeCates SL, Powers SW, Hershey AD. Tolerability and effectiveness of prochlorperazine for intractable migraine in children. Pediatrics. 2001 Apr;107(4):E62. doi: 10.1542/peds.107.4.e62.
- Background: PubMed 14747817Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9.
- Background: PubMed 19150192Trottier ED, Bailey B, Dauphin-Pierre S, Gravel J. Clinical outcomes of children treated with intravenous prochlorperazine for migraine in a pediatric emergency department. J Emerg Med. 2010 Aug;39(2):166-73. doi: 10.1016/j.jemermed.2008.08.012. Epub 2009 Jan 15.
- Background: PubMed 21296523Trottier ED, Bailey B, Lucas N, Lortie A. Prochlorperazine in children with migraine: a look at its effectiveness and rate of akathisia. Am J Emerg Med. 2012 Mar;30(3):456-63. doi: 10.1016/j.ajem.2010.12.020. Epub 2011 Feb 5.
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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.
sarah Kline-Krammes, MD principal investigator
Akron Children's Hospital
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 Ketorolac in people with Migraine, run by Akron Children's Hospital 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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 24 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 the patient's pain score at 60 minutes from administration of the study medications (time frame: 60 minutes from administration of the study medications). 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 NCT01534806, which also lists 14 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 24 Jun 2014.