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治験 NCT06498713（対象：痛み、術後の痛み）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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イェール大学Patient Controlled Administration of Liquid Acetaminophen 第I相・フェーズ1 24
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06498713 は 痛み、術後の痛み に関する 治療 の研究で、第I相・フェーズ1 介入研究 臨床試験 です。現在は 募集中 で、2024年11月19日 から開始しています。24 名の参加者 の募集が計画されています。この試験は イェール大学 によって主導され、2025年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月29日 です。
概要
This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.
詳細説明
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers. Investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen, with more than 50% patient enrollment rate and les...もっと見る
公式タイトル
Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial
疾患名
痛み術後の痛みその他の研究識別子
- 2000037919
NCT番号
開始日
2024-11-19
最終更新日
2025-10-29
終了予定日
2025-12
目標参加者数
24
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
状況
募集中
キーワード
Pain Management
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Nurse Administered Acetaminophen Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care | Acetaminophen 650 mg Oral Tablet 650 mg pills |
実験的CADD pump Administered Acetaminophen (Participant Controlled) Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN). | Acetaminophen 650mg Liquid 650 mg liquid CADD pump Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Participant enrollment rate | The percentage of participants that enroll | up to 12 months |
Participant adherence to the study protocol | Percentage of participants that withdraw from treatment group, i.e. switch from patient controlled liquid group to the nurse-administered pill control group | up to 12 months |
Nurse Questionnaire | Nurse ranking of patient controlled liquid oral acetaminophen vs. nurse-administered pill acetaminophen. (Mean score, Total Scale of 0-10: 0: much worse; 5:same; 10: much better) | Study day 0, 1, 2 and 3 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean daily acetaminophen consumption | Mean daily acetaminophen consumption in milligrams collected using the electronic medical record | 12 months |
Mean Pain score | Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible. | 12 months |
Mean time to medication delivery | Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered | 12 months |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
Participants
- Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty
Nurses
- The nurse who will administer acetaminophen to a study patient.
Participants
- Pregnant patient
- Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)
- Emergency surgery
- Chronic pain
- On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.
- Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder
- History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction
- Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)
- Liver dysfunction limiting amount of safe oral acetaminophen
- baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)
- patients unable to take PO
- Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.
Nurses
- any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the PCA pump.
イェール大学457 件のアクティブな治験を探索試験中央連絡先
連絡先: Jinlei Li, MD, PhD, 475-434-4038, [email protected]
1 1カ国の場所
Connecticut
Yale New Haven Hospital at St. Raphael's Campus, New Haven, Connecticut, 06520, United States
募集中