Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain (Morphine-Mida)
Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.
Administration of midazolam with morphine in patients with severe acute pain is a routine practice in the management of pre- and post-operative patients but has not been evaluated in pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam in the pre-hospital management of traumatic patients with severe acute pain.
In a multicenter prospective randomized double-blind placebo-controlled trial, the investigators would like to compare the analgesic effect and safety of the intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a validated numeric rating scale (NRS).
The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.
연구 개요
상세 설명
Patient will be included in pre-hospital setting. They must have an acute pain NRS greater than or equal to 6 from a traumatic origin. The participation of the study for each patient will be the time of the pre-hospital setting. The study will stop when the patient arrives at the hospital.
Patient will be randomized after obtaining an informed consent. Then, the nurse will administered intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg or intravenous morphine 0.10 mg/kg and placebo.
Only the nurse will be aware of the treatment received by the patient. Every 5 minutes, life constants and pain score will be recorded on the case report form.
Assessment will be done at the baseline using a validated numeric rating scale. The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Brest, 프랑스, 29609
- CHU de Brest
-
Carhaix, 프랑스, 29270
- CH de Carhaix
-
Nantes, 프랑스, 44000
- Chu De Nantes
-
Quimper, 프랑스, 29000
- Centre Hpistalier Intercommunal de Cornouaille
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 to 70 years old
- conscient with spontaneous ventilation
- acute pain with an traumatic origin : pain escape superior or egal to 6/10
- taking care by French reanimation and urgency mobile services (Smur).
Exclusion Criteria:
- younger than 18 years old or older than 70 years old
- chronical respiratory insufficiency
- severe hepatocellular insufficiency,
- myasthenia
- known allergy to morphine or benzodiazepin,
- already treated for a chronical pain,
- pregnant women
- treated by morphine
- patient unable to evaluate his/her pain
- any acute and severe hemodynamic, respiratory or neurologic deficiency
- needed an local analgesia
- patient who received an other antalgic treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Midazolam
Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
|
Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
다른 이름들:
|
|
위약 비교기: Placebo
Placebo at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain score
기간: 20 minutes
|
The primary outcome was the proportion of patients with a pain score less than or equal to 3 after 20 minutes
|
20 minutes
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
pain evolution
기간: every 5 minutes and at the end of the study
|
The secondary outcomes were in between-group comparison of: - pain score every 5 minutes during 30 minutes |
every 5 minutes and at the end of the study
|
|
Safety
기간: during all the study
|
The secondary outcomes were in between-group comparison of: - The treatment safety |
during all the study
|
|
Morphine total dose
기간: During all the study
|
The secondary outcomes were in between-group comparison of: - The total morphine dose required until obtaining pain score less than or equal to 3 |
During all the study
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Yannick AUFFRET, Dr, Centre Hospitalier Intercommunal de Cornouaille
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
급성 외상성 통증에 대한 임상 시험
Midazolam에 대한 임상 시험
-
Al Jedaani Hospital완전한
-
Janssen Research & Development, LLC완전한우울 장애, 전공미국, 프랑스, 이탈리아, 스페인, 헝가리, 벨기에, 브라질, 불가리아, 폴란드