- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03436121
Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department
Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care
연구 개요
상세 설명
The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.
The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.
All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.
연구 유형
단계
- 2 단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults between the ages of 18-65
- A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
- Expected to be in the ED for at least 2 hours
Exclusion Criteria:
- Non-English speaking
- Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns)
- Not alert and oriented
- Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- Seeking treatment due to a mental health or substance use disorder
- History of chronic opioid use
- Prescribed opioid use within the past 24 hours
- Any use of recreational narcotics throughout lifetime
- Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
- Weight > 170kg (375 lbs)
- Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
- Pregnancy
- Prisoner
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Experimental Arm
Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
|
Ketamine is a medication approved by the US Food and Drug Administration (FDA) for anesthesia, sedation, and post-surgical pain treatment.
It is not approved for emergency patients complaining of pain but is often used "off-label."
Ketamine may be useful for acute pain management and in treatment of depressed mood.
The purpose of this study is to determine whether a single low dose of ketamine can relieve pain and reduce negative mood for 2 weeks after emergency department (ED) treatment.
In this study, all patients will also receive midazolam.
Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.
|
활성 비교기: Active Placebo Arm
Participants will be assigned to receive a single dose of IV placebo + midazolam
|
In this study, all patients will also receive midazolam.
Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.
In this study, patients in the active comparator group will receive midazolam first, then placebo.
A placebo is an inactive solution that looks like the study drug, but contains no active ingredients.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pain Intensity in the ED
기간: Pain intensity rating in the ED at 1-hour post-study drug administration
|
Pain Numeric Rating Scale (PNRS)- this item is anchored to pain intensity "right now" on a scale from 0(no pain)-10 (worst pain imaginable)
|
Pain intensity rating in the ED at 1-hour post-study drug administration
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pain Intensity at Follow-Up
기간: Pain Intensity at 1-week post-ED Discharge
|
Pain Numeric Rating Scale (PNRS): this item is anchored to pain intensity within the past 7-days on a scale from 0 (no pain) to 10 (worst pain imaginable)
|
Pain Intensity at 1-week post-ED Discharge
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Maria L Pacella, PhD, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PRO17090065
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Ketamine에 대한 임상 시험
-
Vance Thompson Vision알려지지 않은
-
Complexo Hospitalario Universitario de A Coruña완전한