CephalalgiaPEACENCT02236442
Protocol to Ease Acute Cephalalgia in Emergency-department
A study testing Recommendation to use global headache treatment protocol in people with Cephalalgia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cephalalgia
- What is being tested?
- Recommendation to use global headache treatment protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Sep 2015
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complain about cephalalgia
- Age 28 to 55 years.
Who cannot join
- Fever > 38,0 °C
- History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnea
- History of cranial traumatism, heart attack, cerebrovascular accident <3 month
- Inability to read or understand french.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department
The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.
Read the detailed description
Cephalalgia is a very common symptom that justifies daily appointment in emergency department.
Analgesic support, and especially use of oxygen and care of associated symptoms as nausea, photophobia or phonophobia, is very dependent on the physician.
The aim of this study is to evaluate the impact of a global analgesic protocol of cephalalgia in emergency department.
The investigators included 200 patients aged of 18 up to 55 years old coming in emergency department for headache. Pain (Visual analogic scale), nausea, photo or phonophobia are recorded each 15 minutes by the patient by using a self-assessment questionnaire. The final diagnosis is recorded by the physician in charge of patient, using International Headache Society criteria.
First 100 patients(group 1) receive usual care.
For the last 100 patients (group 2), physician in charge of patients are incited to use a formal protocol that include: putting the patient in a quiet spot, laying down on a stretcher, providing sound proof helmet and light blocking google, administering oxygen therapy 15 l/min during 15 min, and administering etiological headache adapted medication following learned society guidelines.
Comparison of the data of this 2 groups shall help us to see if the investigators actual analgesic support of cephalalgia is efficient, and if it can be improved by this global analgesic protocol.
- Conditions
- Cephalalgia
- Being tested
- Recommendation to use global headache treatment protocol
- Keywords
- Cephalalgia, Headache, Migraine, Pain, Global, Treatment, Oxygen, Emergency, Treatment of cephalalgia in emergency department
- Medical subject headings
- Headache, Migraine Disorders, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendation to use global headache treatment protocolOther
The global treatment protocol is :
- Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor
- Lay down the patient on the stretcher. Avoid waiting on a seat or a chair.
- Provide a sound-proof helmet to the patient.
- Provide a light-blocking google to the patient.
- If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes.
- If judged necessary by the physician in charge of the patient, administer analgesic treatment adapted to the etiology of the cephalalgia as described :
Migraine : acetylsalicilyc acid + metoclopramide or nonsteroidal anti inflammatory or paracetamol or triptan.
Tension headache : nonsteroidal anti inflammatory or paracetamol. Avoid methylmorphine or tramadol if possible.
Cluster headache : Intravenous or nasal spray sumatriptan and oxygen therapy.
Other etiology : Treatment left at the discretion of the physician in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis. |
| After protocol recommendation care | Experimental | Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol Receives: Other: Recommendation to use global headache treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
"Clinical improvement" is defined as "Reduction of at least 50% of quantified pain 1 hour after treatment Comparison of proportion of "clinical improvement" between the 2 groups.
Measured: 1 hour after treatment
Secondary outcomes (6)
Pain score on the visual analog scale
Measure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance).
Comparison between the 2 groups.
Measured: 1 hour after treatment
Pain depending on the kind of cephalalgia
Research of interaction between the occurrence of the "clinical improvement" and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...).
Measured: 1 hour after treatment
Impact of different kind of analgesic therapeutic
Research of interaction between the occurrence of "clinical improvement" and the use of specific therapeutic strategy ( Restful position, calm environment, wearing opaque glasses, soundproof headset, oxygen therapy, other medication, ...)
Measured: 1 hour after treatment
Length of the hospitalization in emergency department
Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups
Measured: Duration of hospitalisation in emergency department stay, an expected average of 6 hours
Time required before medication
Evaluation of the length of time before first administration of analgesic treatment.
Comparison between the 2 groups
Measured: Time of administration of first medication, an expected average of 30 minutes
Hospitalisation requirement
Evaluation of hospitalisation requirement at the exit of emergency department.
Comparison between the 2 groups
Measured: Exit of emergency department, an expected average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CephalalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Mirebeau, Resident, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236442
- Sponsor's protocol ID
- 2014-A00973-44
- Acronym
- PEACE
- Status last verified
- Oct 2016
- First submitted
- 7 Aug 2014
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57. doi: 10.1016/0895-4356(91)90147-2.
PubMed 1941010Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005.
PubMed 19218020Haque B, Rahman KM, Hoque A, Hasan AT, Chowdhury RN, Khan SU, Alam MB, Habib M, Mohammad QD. Precipitating and relieving factors of migraine versus tension type headache. BMC Neurol. 2012 Aug 25;12:82. doi: 10.1186/1471-2377-12-82.
PubMed 22920541Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9;302(22):2451-7. doi: 10.1001/jama.2009.1855.
PubMed 19996400Ozkurt B, Cinar O, Cevik E, Acar AY, Arslan D, Eyi EY, Jay L, Yamanel L, Madsen T. Efficacy of high-flow oxygen therapy in all types of headache: a prospective, randomized, placebo-controlled trial. Am J Emerg Med. 2012 Nov;30(9):1760-4. doi: 10.1016/j.ajem.2012.02.010. Epub 2012 May 3.
PubMed 22560101Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010:1212.
PubMed 21718584B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department
- ClinicalTrials.gov ID
- NCT02236442
- Acronym / sponsor ID
- PEACE / 2014-A00973-44
- Conditions
- Cephalalgia
- Keywords
- Cephalalgia, Headache, Migraine, Pain, Global, Treatment, Oxygen, Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Sep 2014 (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 purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.
Detailed description
Cephalalgia is a very common symptom that justifies daily appointment in emergency department.
Analgesic support, and especially use of oxygen and care of associated symptoms as nausea, photophobia or phonophobia, is very dependent on the physician.
The aim of this study is to evaluate the impact of a global analgesic protocol of cephalalgia in emergency department.
The investigators included 200 patients aged of 18 up to 55 years old coming in emergency department for headache. Pain (Visual analogic scale), nausea, photo or phonophobia are recorded each 15 minutes by the patient by using a self-assessment questionnaire. The final diagnosis is recorded by the physician in charge of patient, using International Headache Society criteria.
First 100 patients(group 1) receive usual care.
For the last 100 patients (group 2), physician in charge of patients are incited to use a formal protocol that include: putting the patient in a quiet spot, laying down on a stretcher, providing sound proof helmet and light blocking google, administering oxygen therapy 15 l/min during 15 min, and administering etiological headache adapted medication following learned society guidelines.
Comparison of the data of this 2 groups shall help us to see if the investigators actual analgesic support of cephalalgia is efficient, and if it can be improved by this global analgesic protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis. |
| After protocol recommendation care | Experimental | Other: Recommendation to use global headache treatment protocolRecording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Complain about cephalalgia
- Age 28 to 55 years.
Key exclusion criteria (5 listed)
- Fever > 38,0 °C
- History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnea
- History of cranial traumatism, heart attack, cerebrovascular accident <3 month
- Inability to read or understand french.
- Pregnancy
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 |
|---|---|---|
| Recommendation to use global headache treatment protocolThe global treatment protocol is : 1. Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor 2. Lay down the patient on the stretcher. Avoid waiting on a seat or a chair. 3. Provide a sound-proof helmet to the patient. 4. Provide a light-blocking google to the patient. 5. If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes. 6. If judged necessary by the physician in charge of the patient, administer analgesic treatment adapted to the etiology of the cephalalgia as described : Migraine : acetylsalicilyc acid + metoclopramide or nonsteroidal anti inflammatory or paracetamol or triptan. Tension headache : nonsteroidal anti inflammatory or paracetamol. Avoid methylmorphine or tramadol if possible. Cluster headache : Intravenous or nasal spray sumatriptan and oxygen therapy. Other etiology : Treatment left at the discretion of the physician in charge of the patient. | Other | After protocol recommendation care |
Primary outcome
Clinical improvement
Time frame: 1 hour after treatment
"Clinical improvement" is defined as "Reduction of at least 50% of quantified pain 1 hour after treatment Comparison of proportion of "clinical improvement" between the 2 groups.
6 secondary outcomes
Pain score on the visual analog scale
Time frame: 1 hour after treatment
Pain depending on the kind of cephalalgia
Time frame: 1 hour after treatment
Impact of different kind of analgesic therapeutic
Time frame: 1 hour after treatment
Length of the hospitalization in emergency department
Time frame: Duration of hospitalisation in emergency department stay, an expected average of 6 hours
Time required before medication
Time frame: Time of administration of first medication, an expected average of 30 minutes
Hospitalisation requirement
Time frame: Exit of emergency department, an expected average of 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Background: PubMed 1941010Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57. doi: 10.1016/0895-4356(91)90147-2.
- Background: PubMed 19218020Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005.
- Background: PubMed 22920541Haque B, Rahman KM, Hoque A, Hasan AT, Chowdhury RN, Khan SU, Alam MB, Habib M, Mohammad QD. Precipitating and relieving factors of migraine versus tension type headache. BMC Neurol. 2012 Aug 25;12:82. doi: 10.1186/1471-2377-12-82.
- Background: PubMed 19996400Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9;302(22):2451-7. doi: 10.1001/jama.2009.1855.
- Background: PubMed 22560101Ozkurt B, Cinar O, Cevik E, Acar AY, Arslan D, Eyi EY, Jay L, Yamanel L, Madsen T. Efficacy of high-flow oxygen therapy in all types of headache: a prospective, randomized, placebo-controlled trial. Am J Emerg Med. 2012 Nov;30(9):1760-4. doi: 10.1016/j.ajem.2012.02.010. Epub 2012 May 3.
- Background: PubMed 21718584Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010:1212.
- BackgroundB. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232
Related trials for Cephalalgia
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
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.
Gabriel Mirebeau, Resident principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommendation to use global headache treatment protocol in people with Cephalalgia, run by University Hospital, Grenoble at 1 site in France.
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 5 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 12 Oct 2016. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical improvement (time frame: 1 hour after treatment). 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 NCT02236442, which also lists 7 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 12 Oct 2016.