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Protocol to Ease Acute Cephalalgia in Emergency-department (PEACE)

Primary Purpose

Cephalalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recommendation to use global headache treatment protocol
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cephalalgia focused on measuring Cephalalgia, Headache, Migraine, Pain, Global, Treatment, Oxygen, Emergency, Treatment of cephalalgia in emergency department

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complain about cephalalgia
  • Age 28 to 55 years.

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

After protocol recommendation care

Arm Description

First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.

Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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...).
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, ...)
Length of the hospitalization in emergency department
Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups
Time required before medication
Evaluation of the length of time before first administration of analgesic treatment. Comparison between the 2 groups
Hospitalisation requirement
Evaluation of hospitalisation requirement at the exit of emergency department. Comparison between the 2 groups

Full Information

First Posted
August 7, 2014
Last Updated
October 11, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02236442
Brief Title
Protocol to Ease Acute Cephalalgia in Emergency-department
Acronym
PEACE
Official Title
Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cephalalgia
Keywords
Cephalalgia, Headache, Migraine, Pain, Global, Treatment, Oxygen, Emergency, Treatment of cephalalgia in emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.
Arm Title
After protocol recommendation care
Arm Type
Experimental
Arm 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(s)
Recommendation to use global headache treatment protocol
Intervention 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.
Primary Outcome Measure Information:
Title
Clinical improvement
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.
Time Frame
1 hour after treatment
Secondary Outcome Measure Information:
Title
Pain score on the visual analog scale
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.
Time Frame
1 hour after treatment
Title
Pain depending on the kind of cephalalgia
Description
Research of interaction between the occurrence of the "clinical improvement" and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...).
Time Frame
1 hour after treatment
Title
Impact of different kind of analgesic therapeutic
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, ...)
Time Frame
1 hour after treatment
Title
Length of the hospitalization in emergency department
Description
Evaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups
Time Frame
Duration of hospitalisation in emergency department stay, an expected average of 6 hours
Title
Time required before medication
Description
Evaluation of the length of time before first administration of analgesic treatment. Comparison between the 2 groups
Time Frame
Time of administration of first medication, an expected average of 30 minutes
Title
Hospitalisation requirement
Description
Evaluation of hospitalisation requirement at the exit of emergency department. Comparison between the 2 groups
Time Frame
Exit of emergency department, an expected average of 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complain about cephalalgia Age 28 to 55 years. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Mirebeau, Resident
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
1941010
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.
Results Reference
background
PubMed Identifier
19218020
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.
Results Reference
background
PubMed Identifier
22920541
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.
Results Reference
background
PubMed Identifier
19996400
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.
Results Reference
background
PubMed Identifier
22560101
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.
Results Reference
background
PubMed Identifier
21718584
Citation
Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010:1212.
Results Reference
background
Citation
B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232
Results Reference
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Protocol to Ease Acute Cephalalgia in Emergency-department

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