None listed
Conditions
Brief summary
The study objective is to compare the analgesic efficacy and quality of postoperative pain relief following minor gynaecological surgery between four different intra-operative analgesic regimens based on opioid plus either paracetamol, parecoxib, paracetamol and parecoxib in combination or placebo. The null hypothesis is that there is no difference in the analgesic efficacy and quality of pain relief provided by either paracetamol, parecoxib, paracetamol and parecoxib in combination or placebo in patients undergoing minor gynaecological surgery.
Interventions
Arm 1: single dose intraoperative intravenous parecoxib 40 mg
Arm 2: single dose intraoperative intravenous paracetamol 2 g
Arm 3: single dose intraoperative intravenous parecoxib 40 mg and intravenous paracetamol 2 g
Arm 4: single dose intraoperative intravenous placebos
This 2 x2 factorial design allows efficient evaluation of two treatments and in this case comparison not only of parecoxib versus placebo and paracetomol versus placebo but also the interaction of these two drugs (both versu
Arm 1: single dose intraoperative intravenous parecoxib 40 mg Arm 2: single dose intraoperative intravenous paracetamol 2 g Arm 3: single dose intraoperative intravenous parecoxib 40 mg and intravenous paracetamol 2 g Arm 4: single dose intraoperative intravenous placebos This 2 x2 factorial design allows efficient evaluation of two treatments and in this case comparison not only of parecoxib versus placebo and paracetomol versus placebo but also the interaction of these two drugs (both versus placebo) and evaluation of all patients receiving each drug eg. Arms 1 & 2 vs Arm 4 and Arms 2 & 3 vs Arm 4.
Sponsors
Women's and Newborn Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Dilatation and curettage American Society of Anesthesiologists physical status 1 or 2
Exclusion criteria
Renal dysfunction Hypertension Ischaemic heart disease Cerebrovascular disease Peptic ulcer or gastro-intestinal reflux disease Aspirin or nonsteroidal anti-inflammatory drug induced asthma Allergy to paracetamol, parecoxib or sulphonamides Hepatic dysfunction Taking analgesic drugs within 24 hours of surgery Unsuitable for anaesthesia with volatile anaesthetics or requiring intubation Prophylactic antiemetic therapy indicated
Outcome results
None listed