A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

348

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

September 14, 2018

Study Completion Date

May 31, 2019

Conditions
Post-operative Analgesia
Interventions
DRUG

Paracetamol injection

325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.

DRUG

Normal Saline injection

32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.

DRUG

Morhpine PCA

Morphine PCA will be connected upon the first dose of study drug(roughly 30min prior to the completion of would suture). Morphine PCA is set as follows:1mg bolus every 5min with background infusion of 0.25mg/h and maximal dose\<25mg/4h.

Trial Locations (16)

100020

Beijing Chao-Yang Hospital, Beijing

100050

Beijing Friendship Hospital, Beijing

100730

Beijing Hospital, Beijing

130021

The First Hospital of Jilin University, Changchun

200065

Tongji Hospital Affiliated to Tongji University, Shanghai

214062

Affiliated Hospital,Jiangnan University, Wuxi

300052

Tianjin Medical University General Hospital, Tianjin

315010

Ningbo No.2 Hospital, Ningbo

350025

Fuzhou General Hospital of Nanjing Millitary Command, Fuzhou

400042

The South West Hospital, Chongqing

410013

the Third Xiangya Hospital of Central South University, Changsha

423000

No.1 People's Hospital of Chenzhou City, Chenzhou

545006

Liuzhou General Hospital, Liuzhou

551100

Guizhou Provincial People's Hospital, Guiyang

610041

West China Hospital, Chengdu

050051

The Third Hospital of Hebei Medical University, Shijiazhuang

All Listed Sponsors
lead

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

NCT02811991 - A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia | Biotech Hunter | Biotech Hunter