Pilot Randomized Control Trial Comparing Oral Ketamine and Oral Oxycodone for Pain Control in Emergency Department Patients (PKORCT)
The goal of this pilot randomized clinical trial is to learn if oral ketamine intervention can control pain in emergency department patients whose providers feel the need for additional pain medication. The main questions it aims to answer are:
- Does oral ketamine result in a different mean change in pain scores compared with oral oxycodone?
- Is there a difference in the need for additional opioid administration within 24 hours after the initial dose of study medication (oral ketamine vs oral oxycodone)?
Researchers will compare oral ketamine to oral oxycodone to see if there is a difference in pain control or the need for additional opioid administration.
Participants will:
- Fill out a survey prior to study medication administration assessing pain scores, pain presentation, and medication history
- Be randomized to and receive a dose of oral ketamine or oral oxycodone as the study medication for pain control
- Fill out a survey assessing pain control, side effects, and safety outcomes
- Receive follow-up phone calls at 1 and 3 months after enrollment to assess pain and opioid use
調査の概要
詳細な説明
In an effort to combat the ongoing opioid crisis, healthcare providers continue to search for alternatives to opioids that are both safe and effective. While no medicine has an ideal profile, oral ketamine have attributes that may serve emergency department (ED) patients well when dealing with painful conditions. While IV ketamine has been well-studied in the ED setting and oral ketamine has been studied in the post-operative setting, there is limited data describing the safety and effectiveness of oral ketamine in the ED setting. Guided by colleagues from the Anesthesia Acute Pain Service, the Albany Medical Center (AMC) ED has begun giving oral ketamine to appropriate ED patients with painful conditions. We aim to conduct a pilot, un-blinded randomized controlled trial to compare the benefits and detriments of oral ketamine vs. oxycodone in ED patients who require 'second line' pain medicine.
A convenience sample of emergency department patients will be randomized to receive either:
Oxycodone arm:
o The treating provider will order oral oxycodone 5 mg times one
or
o The treating provider has made a deliberate decision that the patient requires (because of weight, prior exposures, etc.) greater than oxycodone 5mg times one
Oral ketamine arm:
o The treating provider will order ketamine 0.75 mg/kg oral times one (max 80mg)
Outcomes measured
Participants will be assessed for
- Pain scores at 30 and 60 minutes after either study drug administration
- Whether they received opioids at 6 hours, 12 hours, and 24 hours after receiving either study drug
- For admitted patients, whether they received opioids upon admission to the hospital, and whether they were discharged with a prescription for opioids
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the one month after enrolling in the study
- Whether the participation has received opioid pain medicines, ketamine, or other recreational drugs during the three months after enrolling in the study
We will calculate a difference in change in mean pain scores before and after the intervention in each study arm. We will also compare morphine milli-equivalents use during the time intervals above, as well as usage of opioids, ketamine, and recreational drugs during the one month and three month period after enrollment.
Because this is a pilot study, we have not calculated an effect size.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
New York
-
Albany、New York、アメリカ、12208
- Albany Medical Center Emergency Department
-
コンタクト：
- Michael Waxman, MD
- 電話番号：518-262-3443
- メール：waxmanm@amc.edu
-
コンタクト：
- Andrew Chang, MD, MS
- 電話番号：518-262-3443
- メール：changa1@amc.edu
-
主任研究者：
- Michael Waxman, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- ED patient aged 18 years or older AND
- English proficient AND
- Able to give informed consent AND
- Has a painful condition in the ED that includes any of the following: Musculoskeletal extremity pain, Musculoskeletal back or neck pain, Other nociceptive extremity pain
- AND treating provider has deemed the patient necessitating 'second line pain therapy' (meaning: opioids or ketamine)
Exclusion Criteria:
Any of the following:
- Prisoner status
- Pregnant
- Non-English proficient
- Cannot give informed consent
- Requires emergent intravenous pain medicine (as deemed by the treating provider)
- Prior participation in the study
- Previous diagnosis of opioid use disorder
- Previous ketamine addiction
- Patient is in hospice or other palliative care measures
- Contraindication to ketamine, including: Cystitis or bladder pain, Intracranial hypertension, Known coronary artery disease, Age greater than 75 years old, History of prior adverse reaction to ketamine or oxycodone, History or current major psychiatric disorder (as deemed by the treating ED clinician) or history of psychosis
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：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 |
|---|---|
|
実験的：oral ketamine
The oral ketamine arm will receive a dose of oral ketamine as a second line pain medication.
|
A dose of oral ketamine administered as a second line pain management medicine in the emergency department.
|
|
アクティブコンパレータ：oxycodone
The oxycodone arm will receive a dose of oxycodone as a second line pain medication.
|
A dose of oxycodone administered as a second line pain management medicine in the emergency department.
|
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 |
|---|---|---|
|
Change in mean pain score
時間枠：This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
|
This reflects the mean difference between the pain scores before and after the intervention.
|
This will be assessed at 30 minutes and 60 minutes after receiving the study drugs.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Usage of morphine in the following 24 hours.
時間枠：24 hours
|
Usage of morphine in the following 24 hours.
|
24 hours
|
|
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
時間枠：1 month and 3 months after study enrollment.
|
Usage of opioids, ketamine, or recreational drugs one month and three months after study enrollment.
|
1 month and 3 months after study enrollment.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 7471
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?
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。
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