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Protocol to Ease Acute Cephalalgia in Emergency-department

Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02236442
Acronym
PEACE
Enrollment
200
Registered
2014-09-10
Start date
2014-10-31
Completion date
2015-09-30
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cephalalgia

Keywords

Cephalalgia, Headache, Migraine, Pain, Global, Treatment, Oxygen, Emergency, Treatment of cephalalgia in emergency department

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.

Interventions

OTHERRecommendation to use global headache treatment protocol

The 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.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical improvement1 hour after treatmentClinical 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

MeasureTime frameDescription
Pain depending on the kind of cephalalgia1 hour after treatmentResearch 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 therapeutic1 hour after treatmentResearch 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, ...)
Pain score on the visual analog scale1 hour after treatmentMeasure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance). Comparison between the 2 groups.
Time required before medicationTime of administration of first medication, an expected average of 30 minutesEvaluation of the length of time before first administration of analgesic treatment. Comparison between the 2 groups
Hospitalisation requirementExit of emergency department, an expected average of 6 hoursEvaluation of hospitalisation requirement at the exit of emergency department. Comparison between the 2 groups
Length of the hospitalization in emergency departmentDuration of hospitalisation in emergency department stay, an expected average of 6 hoursEvaluation of the length of the hospitalization in emergency department. Comparison between the 2 groups

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026