Low-dose Ketamine for Acute Pain in the Emergency Department
Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.
The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.
調査の概要
詳細な説明
Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.
Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.
Its use in the ED may probably play a role in maximizing analgesia.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Sousse、チュニジア、4002
- Faculty of Medicine of Sousse
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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:
- Able to understand and give informed consent
- Comfortable with the experimental protocol as outlined to them by the research team
- Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
- Acute pain, pain duration < 7days
- Deemed by treating ED attending physician to require IV opioid analgesia
Exclusion Criteria:
- Neurologic, respiratory, or hemodynamic compromise
- Pregnancy or breastfeeding
- Known or suspected allergy to ketamine or morphine
- Known Renal (Cr>2.0) or Liver Failure
- Unstable psychiatric disease (as per treating physician)
- History of stroke
- History of cardiac disease or coronary artery disease
- History of chronic respiratory disease
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Morphine and Placebo
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg)
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モルヒネ
他の名前：
0.9% normal saline
他の名前：
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実験的：Morphine and Ketamine 0.15
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg
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モルヒネ
他の名前：
ケタミン
他の名前：
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実験的：Morphine and Ketamine 0.3
Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg
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モルヒネ
他の名前：
ケタミン
他の名前：
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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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Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours
時間枠：Two hours after starting protocol
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At baseline, to assess our primary aim, efficacy of pain control, we will use patient reported pain scores and amount of rescue analgesia (parenteral morphine) received. Trained residents will ask participants to report their pains scores using a numerical pain rating scale (NPRS). The NPRS used will be a 0 to 10 rating scale. Baseline NPRS will be measured after randomization, but just before administration of morphine. Change in reported pain score during the protocol will be analysed. The SPID was calculated using the pain-intensity difference (PID) at each of these study time points. The PID for a given time point is equal to the baseline NPRS minus the subsequent NPRS at each study time point. SPID is the summation of the PID at each of the study time points, weighted using the amount of time since the prior assessment |
Two hours after starting protocol
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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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Total patient-perceived pain relief
時間枠：Two hours after starting protocol
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The total patient-perceived pain relief will be calculated using weighted sum of the pain relief scale performed at each study time point.
This pain relief scale is a five-point scale that asks participants to rate pain relief as complete = 4, a lot = 3, some = 2, a little = 1, and none = 0
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Two hours after starting protocol
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Amount of rescue analgesia received
時間枠：Two hours after starting protocol
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The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.
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Two hours after starting protocol
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Time to rescue analgesia
時間枠：Two hours after starting protocol
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Time to rescue analgesia will be calculated as the time from administration of the last study medication (placebo or ketamine) to administration of an opioid analgesic.
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Two hours after starting protocol
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The occurrence of adverse events
時間枠：Two hours after starting protocol
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We will record participant-reported dizziness, nausea, vomiting, confusion, dysphoria, visual disturbances, or other complaints at baseline and each study time point. All patients will be monitored for the duration of the study period and vital signs will be recorded at each time point. The presence of tachycardia (heart rate > 100 beats/min.), hypotension (systolic blood pressure [sBP] < 100 mm Hg), hypertension (sBP > 180 mm Hg or diastolic blood pressure [dBP] > 100 mm Hg), and respiratory depression (respiratory rate < 12 breaths/min, oxygen saturation < 92%, or need for supplemental oxygen) will be noted. |
Two hours after starting protocol
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The total dose of morphine administered
時間枠：Two hours after starting protocol
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The amount of rescue analgesia will be recorded at each time point and the total dose calculated
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Two hours after starting protocol
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協力者と研究者
捜査官
- 主任研究者：Hajer KRAIEM, MD、Faculty of Medicine of Sousse
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 (予想される)
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。
痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了