Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
2020年3月6日 更新者：Albert Einstein Healthcare Network
"Does a 1 Plus 1 Hydromorphone Pain Protocol Have a Similar Rate of Respiratory Depression to Physician Discretion Protocol in a Geriatric Population With Moderate to Severe Pain?"
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of moderate to sever pain in the Emergency Department.
Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be enrolled in one of two study arms, "1+1" versus usual care group.
1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes if pain persists.
Usual care group patients will have pain treated per the discretion of the attending physician.
Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.
調査の概要
詳細な説明
This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management protocol for the treatment of long bone fractures in the Emergency Department.
Appropriate patients 60 years and older who present with a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia will be screened and randomized to one of two study arms, "1+1" versus usual care group.
Neither the research associate, nurse, or attending physician will be blinded to the patients randomization.
Patient pain score will be assessed at baseline using VAS score.
"1+1" patients will receive 1mg hydromorphone at "timepoint 0" (baseline) followed by another 1mg after 15 minutes (along with repeat VAS pain score) if the patient answers "yes" to "Do you need more pain medicine?"
At 60 minutes, patient pain will be assessed a final time and if patient needs more pain medicine, additional treatment will be dictated by physician discretion.
Usual care group patients will also have VAS pain scores assessed at timepoint 0, 15 and 60 minutes and will have pain treated per the discretion of the attending physician.
Patients will be placed on capnometer for continuous monitoring of respiratory status to guard against any opioid induced respiratory depression.
Respiratory status, vital signs, and pain scores will be monitor to assess the efficiency of pain control as well as the safety of pain medicine administration in terms of respiratory depression.
We propose that the "1+1" hydromorphone protocol is easy to implement, as it includes a set timeline, a standard question, and a set dosage of a potent analgesic.
We hypothesize that it will provide adequate analgesia in the majority of patients without causing the anticipated level of respiratory depression.
研究の種類
介入
入学 (実際)
116
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19141
- Albert Einstein Medical Center
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Any patient who presents a condition that causes moderate to severe pain, according to the attending physician's judgment, in which the physician would order the use of parenteral analgesia
- Able to provide consent.
Exclusion Criteria:
- Patient or family member unable to consent
- Altered mental status
- SpO2 less than 95 percent
- Allergy to opiates
- Hypotension (Systolic blood pressure less than 90 mmHg)
- Chronic oxygen dependency or known CO2 retention
- Acute ETOH or drug intoxication
- History of chronic pain syndrome or chronic use of opiate narcotics
- History of opiate/heroin addiction, past or current.
- End stage renal disease/dialysis patient
- Chronic metabolic acidosis
- Physician feels that patient would be poor candidate for study
- Weight less than 100 pounds, all patients will be weighted
- Patients younger than 60 years of age
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 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 |
|---|---|
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アクティブコンパレータ：1mg + 1mg Hydromorphone
Patient will receive 1 mg of hydromorphone for pain at timepoint 0. After 15 minutes, patients will be asked if the still need pain medication.
If yes, patients will immediately receive 1mg hydromorphone.
Patients will be under continuous monitoring for respiratory depression via capnometer.
At 60 minutes, pain will be re-assessed for a second time.
If needed, physician will give additional pain meds per their discretion.
|
1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.
他の名前：
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アクティブコンパレータ：Usual Care Group
Patient will receive pain medicine per doctor's discretion at timepoint 0. After 15 minutes, patients will be asked if they still need pain medication.
If yes, physicians will not be notified and patient will continue to have pain managed as deemed necessary by physician per "usual care."
Patients will be under continuous monitoring for respiratory depression via capnometer.
At 60 minutes, pain will be re-assessed for a second time.
If needed, physician will give additional pain meds per their discretion.
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Patient will have pain treated at timepoint 0 as per usual care based on physician discretion.
At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion.
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 |
|---|---|---|
|
Respiratory Depression
時間枠：From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater)
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
|
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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Successful Treatment of Patient Pain
時間枠：15 min and 60 min after baseline
|
Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes
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15 min and 60 min after baseline
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Change in VAS Score
時間枠：15 min and 60 min after baseline
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A 13 mm change or greater on a VAS score
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15 min and 60 min after baseline
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Hypoxia
時間枠：From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Defined as SpO2 of 93% or less for 15 seconds
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Hypotension
時間枠：Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
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Hypotension defined as systolic blood pressure less than 90 mmHg
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Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)
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Allergic Reaction to Study Drug
時間枠：From administration of drug (time 0 minutes) to end of study (60 minute mark)
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
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|
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Serious Adverse Events
時間枠：From administration of drug (time 0 minutes) to end of study (60 minute mark)
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Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.
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From administration of drug (time 0 minutes) to end of study (60 minute mark)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2011年12月1日
一次修了 (実際)
2014年4月16日
研究の完了 (実際)
2014年4月16日
試験登録日
最初に提出
2012年6月25日
QC基準を満たした最初の提出物
2013年2月5日
最初の投稿 (見積もり)
2013年2月6日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月19日
QC基準を満たした最後の更新が送信されました
2020年3月6日
最終確認日
2016年12月1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
- HN - 4325
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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痛みの臨床試験
-
Dexa Medica Group完了
Hydromorphoneの臨床試験
-
Alza Corporation, DE, USA完了