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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Isere
-
Grenoble、Isere、フランス、38700
- University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Usual care
First arm : Passive recording head pain, linked symptoms, treatment used and diagnosis.
|
|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical improvement
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain score on the visual analog scale
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Gabriel Mirebeau, Resident、University Hospital, Grenoble
出版物と役立つリンク
一般刊行物
- 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
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。