<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236442</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00973-44</org_study_id>
    <nct_id>NCT02236442</nct_id>
  </id_info>
  <brief_title>Protocol to Ease Acute Cephalalgia in Emergency-department</brief_title>
  <acronym>PEACE</acronym>
  <official_title>Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the use of a therapeutic and global protocol to&#xD;
      relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cephalalgia is a very common symptom that justifies daily appointment in emergency&#xD;
      department.&#xD;
&#xD;
      Analgesic support, and especially use of oxygen and care of associated symptoms as nausea,&#xD;
      photophobia or phonophobia, is very dependent on the physician.&#xD;
&#xD;
      The aim of this study is to evaluate the impact of a global analgesic protocol of cephalalgia&#xD;
      in emergency department.&#xD;
&#xD;
      The investigators included 200 patients aged of 18 up to 55 years old coming in emergency&#xD;
      department for headache. Pain (Visual analogic scale), nausea, photo or phonophobia are&#xD;
      recorded each 15 minutes by the patient by using a self-assessment questionnaire. The final&#xD;
      diagnosis is recorded by the physician in charge of patient, using International Headache&#xD;
      Society criteria.&#xD;
&#xD;
      First 100 patients(group 1) receive usual care.&#xD;
&#xD;
      For the last 100 patients (group 2), physician in charge of patients are incited to use a&#xD;
      formal protocol that include: putting the patient in a quiet spot, laying down on a&#xD;
      stretcher, providing sound proof helmet and light blocking google, administering oxygen&#xD;
      therapy 15 l/min during 15 min, and administering etiological headache adapted medication&#xD;
      following learned society guidelines.&#xD;
&#xD;
      Comparison of the data of this 2 groups shall help us to see if the investigators actual&#xD;
      analgesic support of cephalalgia is efficient, and if it can be improved by this global&#xD;
      analgesic protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>1 hour after treatment</time_frame>
    <description>&quot;Clinical improvement&quot; is defined as &quot;Reduction of at least 50% of quantified pain 1 hour after treatment Comparison of proportion of &quot;clinical improvement&quot; between the 2 groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score on the visual analog scale</measure>
    <time_frame>1 hour after treatment</time_frame>
    <description>Measure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance).&#xD;
Comparison between the 2 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain depending on the kind of cephalalgia</measure>
    <time_frame>1 hour after treatment</time_frame>
    <description>Research of interaction between the occurrence of the &quot;clinical improvement&quot; and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of different kind of analgesic therapeutic</measure>
    <time_frame>1 hour after treatment</time_frame>
    <description>Research of interaction between the occurrence of &quot;clinical improvement&quot; and the use of specific therapeutic strategy ( Restful position, calm environment, wearing opaque glasses, soundproof headset, oxygen therapy, other medication, ...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of the hospitalization in emergency department</measure>
    <time_frame>Duration of hospitalisation in emergency department stay, an expected average of 6 hours</time_frame>
    <description>Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time required before medication</measure>
    <time_frame>Time of administration of first medication, an expected average of 30 minutes</time_frame>
    <description>Evaluation of the length of time before first administration of analgesic treatment.&#xD;
Comparison between the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisation requirement</measure>
    <time_frame>Exit of emergency department, an expected average of 6 hours</time_frame>
    <description>Evaluation of hospitalisation requirement at the exit of emergency department.&#xD;
Comparison between the 2 groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Cephalalgia</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>After protocol recommendation care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Recommendation to use global headache treatment protocol</intervention_name>
    <description>The global treatment protocol is :&#xD;
Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor&#xD;
Lay down the patient on the stretcher. Avoid waiting on a seat or a chair.&#xD;
Provide a sound-proof helmet to the patient.&#xD;
Provide a light-blocking google to the patient.&#xD;
If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes.&#xD;
If judged necessary by the physician in charge of the patient, administer analgesic treatment adapted to the etiology of the cephalalgia as described :&#xD;
Migraine : acetylsalicilyc acid + metoclopramide or nonsteroidal anti inflammatory or paracetamol or triptan.&#xD;
Tension headache : nonsteroidal anti inflammatory or paracetamol. Avoid methylmorphine or tramadol if possible.&#xD;
Cluster headache : Intravenous or nasal spray sumatriptan and oxygen therapy.&#xD;
Other etiology : Treatment left at the discretion of the physician in charge of the patient.</description>
    <arm_group_label>After protocol recommendation care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complain about cephalalgia&#xD;
&#xD;
          -  Age 28 to 55 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fever &gt; 38,0 °C&#xD;
&#xD;
          -  History of breath disease, long term use of oxygen therapy, chronic obstructive&#xD;
             pulmonary disease, dyspnea&#xD;
&#xD;
          -  History of cranial traumatism, heart attack, cerebrovascular accident &lt;3 month&#xD;
&#xD;
          -  Inability to read or understand french.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel Mirebeau, Resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Grenoble</city>
        <state>Isere</state>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>1941010</PMID>
  </reference>
  <reference>
    <citation>Friedman 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.</citation>
    <PMID>19218020</PMID>
  </reference>
  <reference>
    <citation>Haque 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.</citation>
    <PMID>22920541</PMID>
  </reference>
  <reference>
    <citation>Cohen 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.</citation>
    <PMID>19996400</PMID>
  </reference>
  <reference>
    <citation>Ozkurt 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.</citation>
    <PMID>22560101</PMID>
  </reference>
  <reference>
    <citation>Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010:1212.</citation>
    <PMID>21718584</PMID>
  </reference>
  <reference>
    <citation>B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232</citation>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 11, 2016</last_update_submitted>
  <last_update_submitted_qc>October 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cephalalgia</keyword>
  <keyword>Headache</keyword>
  <keyword>Migraine</keyword>
  <keyword>Pain</keyword>
  <keyword>Global</keyword>
  <keyword>Treatment</keyword>
  <keyword>Oxygen</keyword>
  <keyword>Emergency</keyword>
  <keyword>Treatment of cephalalgia in emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236442
org study id: 2014-A00973-44
nct id: NCT02236442
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical improvement
time frame: 1 hour after treatment
description: "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.
measure: Pain score on the visual analog scale
time frame: 1 hour after treatment
description: Measure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance).
Comparison between the 2 groups.
measure: Pain depending on the kind of cephalalgia
time frame: 1 hour after treatment
description: Research of interaction between the occurrence of the "clinical improvement" and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...).
measure: Impact of different kind of analgesic therapeutic
time frame: 1 hour after treatment
description: 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, ...)
measure: Length of the hospitalization in emergency department
time frame: Duration of hospitalisation in emergency department stay, an expected average of 6 hours
description: Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups
measure: Time required before medication
time frame: Time of administration of first medication, an expected average of 30 minutes
description: Evaluation of the length of time before first administration of analgesic treatment.
Comparison between the 2 groups
measure: Hospitalisation requirement
time frame: Exit of emergency department, an expected average of 6 hours
description: Evaluation of hospitalisation requirement at the exit of emergency department.
Comparison between the 2 groups
arm group label: Usual care
arm group type: No Intervention
description: First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.
arm group label: After protocol recommendation care
arm group type: Experimental
description: Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol
intervention type: Other
intervention name: Recommendation to use global headache treatment protocol
description: 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.
arm group label: After protocol recommendation care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Gabriel Mirebeau, Resident
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
citation: 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.
PMID: 1941010
citation: Friedman 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.
PMID: 19218020
citation: Haque 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.
PMID: 22920541
citation: Cohen 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.
PMID: 19996400
citation: Ozkurt 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.
PMID: 22560101
citation: Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010:1212.
PMID: 21718584
citation: B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Headache