Parecoxib and paracetamol for pain relief following minor day stay gynaecological surgery (The PAINFREE Trial)
Early postoperative analgesia from parecoxib, paracetamol or both among patients having minor gynaecological sugery
Women's and Newborn Health Service
240 participants
Apr 19, 2011
Interventional
Conditions
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.
Eligibility
Inclusion Criteria2
- Dilatation and curettage
- American Society of Anesthesiologists physical status 1 or 2
Exclusion Criteria11
- 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
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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 versus placebo) and evaluation of all patients receiving each drug eg. Arms 1 & 2 vs Arm 4 and Arms 2 & 3 vs Arm 4.
Locations(1)
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ACTRN12611000345987