Protocol to Ease Acute Cephalalgia in Emergency-department (PEACE)
Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Isere
-
Grenoble, Isere, Francie, 38700
- University Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Usual care
First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.
|
|
|
Experimentální: After protocol recommendation care
Recording head pain, linked symptoms, treatment used and diagnosis after intervention that is recommendation to use global headache treatment protocol
|
The global treatment protocol is :
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical improvement
Časové okno: 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.
|
1 hour after treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain score on the visual analog scale
Časové okno: 1 hour after treatment
|
Measure of amount of pain by recording quantified pain evaluation each 15 minutes. Analysis by ANOVA (Analysis of Variance). Comparison between the 2 groups. |
1 hour after treatment
|
|
Pain depending on the kind of cephalalgia
Časové okno: 1 hour after treatment
|
Research of interaction between the occurrence of the "clinical improvement" and the cephalalgia diagnosis (Migraine, tensive headache, cluster headache, secondary headache...).
|
1 hour after treatment
|
|
Impact of different kind of analgesic therapeutic
Časové okno: 1 hour after treatment
|
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, ...)
|
1 hour after treatment
|
|
Length of the hospitalization in emergency department
Časové okno: Duration of hospitalisation in emergency department stay, an expected average of 6 hours
|
Evaluation of the length of the hospitalization in emergency department.
Comparison between the 2 groups
|
Duration of hospitalisation in emergency department stay, an expected average of 6 hours
|
|
Time required before medication
Časové okno: Time of administration of first medication, an expected average of 30 minutes
|
Evaluation of the length of time before first administration of analgesic treatment. Comparison between the 2 groups |
Time of administration of first medication, an expected average of 30 minutes
|
|
Hospitalisation requirement
Časové okno: Exit of emergency department, an expected average of 6 hours
|
Evaluation of hospitalisation requirement at the exit of emergency department. Comparison between the 2 groups |
Exit of emergency department, an expected average of 6 hours
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Gabriel Mirebeau, Resident, University Hospital, Grenoble
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010:1212.
- B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2014-A00973-44
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