Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department
Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in Pediatric Patients Presenting to the Emergency Department With Migraine: A Pilot Randomized Controlled Trial
調査の概要
詳細な説明
Migraine is common in the pediatric emergency department. Unfortunately, somewhere between one third and two thirds of children and adolescents will have recurrence of their migraine within a week of discharge from the emergency department. Although there is strong evidence from adult studies that dexamethasone can prevent migraine recurrence, there is no evidence on how to prevent recurrence in children and adolescents. The proposed study will randomly assign children and adolescents visiting the Children's Hospital of Eastern Ontario (CHEO) emergency department (ED) for migraine to receive either one dose of oral dexamethasone or oral placebo. Twenty patients will be recruited to this randomized, double-blind, pilot trial over a 6 month period, and the aim of the study will be to determine the feasibility and acceptability of the protocol.
Patients will be recruited from the CHEO ED. Research volunteers will screen patients with a triage diagnosis of 'headache', 'migraine' or a related triage diagnosis for eligibility. Patients who meet eligibility criteria will be approached by a research assistant who will initiate the consent process. Informed consent will be sought through both verbal explanation and in written form, from participants 14 years and over and from the parent(s) or guardian(s). For participants under the age of 14 years, verbal and written assent will be sought.
Consenting participants will be randomized to receive one dose of oral dexamethasone 0.6mg/kg to a maximum of 15mg or one dose of oral matched placebo. Randomization will be stratified by baseline migraine duration: 1) less than 2 hours, 2) 2 hours to less than 24 hours and 3) 24 hours and greater. A list of randomization codes will be generated over the computer by a biostatistician and randomization will occur in blocks of four. Research personnel will not have access to the randomization code list with group assignments. Only the research pharmacists will have access to the list.
The research assistants will collect outcome data from the participants and store it into Research Electronic Data Capture (REDCaP), a secure, encrypted web-based platform. Participants will have the option of completing follow-up via email questionnaires or over the telephone. Follow-up will take place 48 hours and 7 days after discharge. The purpose of follow-up will be to assess whether or not participants had recurrence of their migraine, and to collect other follow-up outcome data and safety data. The research assistants, participants, research personnel and clinical personnel will all be blinded to group assignment. Only the research pharmacists, who will not interact with anyone in the study directly, will have access to group assignment information.
Data analyses will be carried out for exploratory purposes, and the groups (dexamethasone vs. placebo) will be compared with regards to: baseline data, 48 hour migraine recurrence rates, 7 day migraine recurrence rates, the proportion of participants achieving pain freedom at 2 hours and maintaining it at 48 hours, patient satisfaction data and adverse events.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1H 8L1
- Children's Hospital of Eastern Ontario
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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:
- Between the ages of 8 and 18 years (ie. > 8.0 years and < 18.0 years)
- Diagnosed with migraine according to a modified version of International Classification of Headache Disorders 3rd edition (ICHD-3, beta version) where criterion A (ie. minimum of 5 prior episodes meeting criteria B-D) has been removed to increase sensitivity of diagnosis in the emergency department setting
Exclusion Criteria:
- Received a dose of a steroid medication in the past 7 days
- Known allergy to dexamethasone
- Immunosuppressed
- Cushing's syndrome
- Known diabetes mellitus
- Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative colitis)
- Known myasthenia gravis
- Glaucoma
- Febrile at triage
- History of head trauma in the past 7 days
- Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed with active infection in the ED, etc)
- Current secondary headache (as per the treating physician's clinical impression)
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Dexamethasone
Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
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Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
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プラセボコンパレーター：Placebo
Matched oral solution in same volume per kg as dexamethasone
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Matched oral solution
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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 |
|---|---|---|
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Headache Recurrence at 48 Hours
時間枠：48 hours
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The primary outcome will be headache recurrence 48 hours after discharge from the ED.
Headache recurrence will be defined as: for patients who were pain-free at ED discharge (ie.
pain intensity of 0), any return of head pain (ie.
pain intensity of 1 or greater) will be coded as a recurrence, and for patients who had persistent head pain at discharge, an increase in head pain since ED discharge will be coded as recurrence as well (ie.
an increase in their score on the 4-point scale as compared to their score at ED discharge).
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48 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity
時間枠：Baseline, 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours)
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Pain intensity will be measured on a 4 point rating scale as recommended by the International Headache Society guidelines: a) 0=none, b) 1=mild, c) 2= moderate, d) 4=severe.
It will be assessed at 2 hours post-baseline, or at the time of ED discharge if prior to 2 hours and at the time of ED discharge where this exceeds 2 hours post-intervention.
Because all participants were discharged prior to 2 hours, we report the pain intensity at the time of ED discharge.
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Baseline, 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours)
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Persistent Pain Freedom
時間枠：2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours
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Persistent pain freedom, defined as the proportion of patients in each group who achieved pain freedom at 2 hours (or at the time of ED discharge if prior to 2 hours) and were free of pain without the use of rescue medication at 48 hours, will be assessed
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2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours
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Patient Satisfaction
時間枠：At the time of discharge from the ED (expected median duration in the ED post-treatment = 3 hours), at 48 hours and at 7 day follow-up
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Patient satisfaction will be assessed at the time of discharge from the ED and again at follow-up with the following 5-point Likert scale: 5=very satisfied, 4=satisfied, 3=neutral, 2=unsatisfied, 1=very unsatisfied.
Here we report patient satisfaction rates at discharge.
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At the time of discharge from the ED (expected median duration in the ED post-treatment = 3 hours), at 48 hours and at 7 day follow-up
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Headache Recurrence at 7 Day Follow-up
時間枠：7 days
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The proportion of patients in each group with recurrence within the 7 days following ED discharge will be assessed.
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7 days
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Revisits Within 7 Days of Discharge From the ED
時間枠：7 days
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The number of patients with return ED visits within 7 days of ED discharge will be assessed through chart review.
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7 days
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Adverse Events at Discharge
時間枠：2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
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Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days.
Reported here are the adverse events at the time of ED discharge.
All patients were discharged prior to the 2 hour time point.
Adverse events reported at follow-up are reported elsewhere (see below).
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2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
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Adverse Events at 48 Hours Post-discharge
時間枠：2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
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Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days.
Reported here are the adverse events at the 48 hour follow-up post-discharge.
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2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
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Adverse Events at 7 Days Post-discharge
時間枠：2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
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Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days.
Reported here are the adverse events at the 7 day follow-up post-discharge.
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2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days
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協力者と研究者
捜査官
- 主任研究者：Roger Zemek, MD、Children's Hospital of Eastern Ontario
出版物と役立つリンク
一般刊行物
- Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.
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 (実際)
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。
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