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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
-
-
New York
-
Albany, New York, 미국, 12208
- Albany Medical Center Emergency Department
-
연락하다:
- Michael Waxman, MD
- 전화번호: 518-262-3443
- 이메일: waxmanm@amc.edu
-
연락하다:
- Andrew Chang, MD, MS
- 전화번호: 518-262-3443
- 이메일: changa1@amc.edu
-
수석 연구원:
- Michael Waxman, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in mean pain score
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Usage of morphine in the following 24 hours.
기간: 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.
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 7471
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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