Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department
Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care
調査の概要
詳細な説明
The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.
The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.
All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.
研究の種類
段階
- フェーズ2
- フェーズ 3
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:
- Adults between the ages of 18-65
- A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
- Expected to be in the ED for at least 2 hours
Exclusion Criteria:
- Non-English speaking
- Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns)
- Not alert and oriented
- Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- Seeking treatment due to a mental health or substance use disorder
- History of chronic opioid use
- Prescribed opioid use within the past 24 hours
- Any use of recreational narcotics throughout lifetime
- Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
- Weight > 170kg (375 lbs)
- Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
- Pregnancy
- Prisoner
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 |
---|---|
実験的:Experimental Arm
Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
|
Ketamine is a medication approved by the US Food and Drug Administration (FDA) for anesthesia, sedation, and post-surgical pain treatment.
It is not approved for emergency patients complaining of pain but is often used "off-label."
Ketamine may be useful for acute pain management and in treatment of depressed mood.
The purpose of this study is to determine whether a single low dose of ketamine can relieve pain and reduce negative mood for 2 weeks after emergency department (ED) treatment.
In this study, all patients will also receive midazolam.
Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.
|
アクティブコンパレータ:Active Placebo Arm
Participants will be assigned to receive a single dose of IV placebo + midazolam
|
In this study, all patients will also receive midazolam.
Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.
In this study, patients in the active comparator group will receive midazolam first, then placebo.
A placebo is an inactive solution that looks like the study drug, but contains no active ingredients.
|
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 |
---|---|---|
Pain Intensity in the ED
時間枠:Pain intensity rating in the ED at 1-hour post-study drug administration
|
Pain Numeric Rating Scale (PNRS)- this item is anchored to pain intensity "right now" on a scale from 0(no pain)-10 (worst pain imaginable)
|
Pain intensity rating in the ED at 1-hour post-study drug administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Pain Intensity at Follow-Up
時間枠:Pain Intensity at 1-week post-ED Discharge
|
Pain Numeric Rating Scale (PNRS): this item is anchored to pain intensity within the past 7-days on a scale from 0 (no pain) to 10 (worst pain imaginable)
|
Pain Intensity at 1-week post-ED Discharge
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Maria L Pacella, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始 (予想される)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PRO17090065
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。