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Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

2019年8月13日 更新者：Defense and Veterans Center for Integrative Pain Management

A Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a retrospective study to determine if there is a relationship between intravenous infusion of ketamine given for analgesia and the use of additional opioid pain medications and patient reported pain levels before and during ketamine usage. The investigator anticipates that records of up to 700 subjects will be reviewed for eligibility. The time period 24 hours before the initial ketamine therapy is initiated along with 24 & 48 hours after the start of ketamine therapy will be the time periods examined. The average/minimum/maximum pain scores during these time periods will be used. Medication usage will be calculated over the 24 hour time periods.

This protocol is presented as an initial step in exploring the possible relationship between the administration of ketamine as an analgesic agent, the potential reduction in pain medications, and the potential reduction of pain levels. With this the goals/objectives are as follows:

Objectives

  1. To compare morphine consumption in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
  2. To compare average/minimum/maximum pain scores in battlefield injured patients with acute pain 24 hours before the initiation of a ketamine infusion to the subsequent 48 hours following the start of infusion.
  3. To describe the pain trajectory in battlefield injured patients with acute pain after the initiation of ketamine infusions.
  4. To measure the absolute and proportional incidence of ketamine associated side effects in battlefield injured patients with acute pain following the initiation of ketamine infusions.

研究の種類

観察的

入学 (実際)

80

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

  • アメリカ
    • Maryland
      • Bethesda、Maryland、アメリカ、20889
        • Walter Reed National Military Medical Center

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

18年歳以上 (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

サンプリング方法

確率サンプル

調査対象母集団

Male and female military health care beneficiaries age 18 years and older

説明

Inclusion Criteria:

  • Battlefield injured from January 2007 to December 2013
  • Prescribed a ketamine infusion for acute pain
  • Awake, alert (non intubated/sedated), and able to report pain scores 24 hours prior to the start of infusion and up to 48 hours following infusion

Exclusion Criteria:

  • Patients who did not receive an injury in theater and did not receive ketamine while being treated by the APS or WRNMMC/WRAMC hospital staff
  • No continuous perineural catheter or epidural placement while on ketamine infusion
  • Less than 18 years old

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

コホートと介入

グループ/コホート
介入・治療
Battlefield Injury with ketamine treatment
Patients who received ketamine infusions to treat pain from January 2007 to December 2013.
薬：ケタミン

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
Opioid consumption measured in morphine equivalents
時間枠：24 hours before ketamine infusion
Amount of opioids consumed within time frame
24 hours before ketamine infusion
Opioid consumption measured in morphine equivalents
時間枠：24 hours after ketamine infusion
Amount of opioids consumed within time frame
24 hours after ketamine infusion
Opioid consumption measured in morphine equivalents
時間枠：48 hours after ketamine infusion
Amount of opioids consumed within time frame
48 hours after ketamine infusion
Pain scores
時間枠：24 hours before ketamine infusion

Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale

Rate the severity of your CURRENT pain:

0 - No Pain

  1. - Hardly notice pain
  2. - Notice pain, does not interfere with activities
  3. - Sometimes distracts me
  4. - Distracts me, can do usual activities
  5. - Interrupts some activities
  6. - Hard to ignore, avoid usual activities
  7. - Focus of attention, prevents doing daily activities
  8. - Awful, hard to do anything
  9. - Can't bear pain, unable to do anything
  10. - As bad as it could be, nothing else matters

Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity:

0 - 10 (0=does not interfere, 10=completely interferes)

Circle the number that describes how, during the past 24 hours, pain has interfered with sleep:

0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10
24 hours before ketamine infusion
Pain scores
時間枠：24 hours after ketamine infusion

Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale

Rate the severity of your CURRENT pain:

0 - No Pain

  1. - Hardly notice pain
  2. - Notice pain, does not interfere with activities
  3. - Sometimes distracts me
  4. - Distracts me, can do usual activities
  5. - Interrupts some activities
  6. - Hard to ignore, avoid usual activities
  7. - Focus of attention, prevents doing daily activities
  8. - Awful, hard to do anything
  9. - Can't bear pain, unable to do anything
  10. - As bad as it could be, nothing else matters

Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity:

0 - 10 (0=does not interfere, 10=completely interferes)

Circle the number that describes how, during the past 24 hours, pain has interfered with sleep:

0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10
24 hours after ketamine infusion
Pain scores
時間枠：48 hours after ketamine infusion

Defense and Veterans Pain Rating Scale Pain scores recorded based on the Defense and Veterans Pain Rating Scale

Rate the severity of your CURRENT pain:

0 - No Pain

  1. - Hardly notice pain
  2. - Notice pain, does not interfere with activities
  3. - Sometimes distracts me
  4. - Distracts me, can do usual activities
  5. - Interrupts some activities
  6. - Hard to ignore, avoid usual activities
  7. - Focus of attention, prevents doing daily activities
  8. - Awful, hard to do anything
  9. - Can't bear pain, unable to do anything
  10. - As bad as it could be, nothing else matters

Circle the number that describes how, during the past 24 hours, pain has interfered with your usual activity:

0 - 10 (0=does not interfere, 10=completely interferes)

Circle the number that describes how, during the past 24 hours, pain has interfered with sleep:

0 - 10 (0=does not interfere, 10=completely interferes) Circle the number that describes how, during the past 24 hours, pain has affected your mood: 0-10
48 hours after ketamine infusion
Number of ketamine side effects
時間枠：24 hours before ketamine infusion
Recorded side effects after ketamine infusion
24 hours before ketamine infusion
Number of ketamine side effects
時間枠：24 after ketamine infusion
Recorded side effects after ketamine infusion
24 after ketamine infusion
Number of ketamine side effects
時間枠：48 hours after ketamine infusion
Recorded side effects after ketamine infusion
48 hours after ketamine infusion

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。

スポンサー

Defense and Veterans Center for Integrative Pain Management

捜査官

  • 主任研究者：Michael Kent, MD、Walter Reed National Military Medical Center

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

2014年8月1日

一次修了 (実際)

2017年8月1日

研究の完了 (実際)

2017年8月30日

試験登録日

最初に提出

2019年8月12日

QC基準を満たした最初の提出物

2019年8月13日

最初の投稿 (実際)

2019年8月15日

学習記録の更新

投稿された最後の更新 (実際)

2019年8月15日

QC基準を満たした最後の更新が送信されました

2019年8月13日

最終確認日

2019年8月1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

  • 399623

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