None listed
Conditions
Brief summary
We wish to determine if the use of Maxigesic (combination paracetamol/ibuprofen) available in both an intravenous and oral formulation provides superior analgesia for women having an elective caesarean section, as determined using the Short Form McGill Pain Questionnaire on days 1 and 2 postoperatively.
Interventions
Intervention A: Intraoperative IV 40 mg parecoxib and IV 1g paracetamol is administered by the attending anaesthetist. Parecoxib is a lyophilised powder that is reconstituted with 5 ml normal saline. Paracetamol is provided as 1000 mg in 100 ml solution for infusion. Postoperative regular oral paracetamol 1 g every 6 hours and regular oral ibuprofen 400 mg every 8 hours, with the first dose of oral ibuprofen being given no less than 12 hours post IV parecoxib, is administered by the midwife cari
Intervention A: Intraoperative IV 40 mg parecoxib and IV 1g paracetamol is administered by the attending anaesthetist. Parecoxib is a lyophilised powder that is reconstituted with 5 ml normal saline. Paracetamol is provided as 1000 mg in 100 ml solution for infusion. Postoperative regular oral paracetamol 1 g every 6 hours and regular oral ibuprofen 400 mg every 8 hours, with the first dose of oral ibuprofen being given no less than 12 hours post IV parecoxib, is administered by the midwife caring for the participant. Paracetamol and ibuprofen are supplied as tablets. Intervention B: Intaoperative IV Maxegisic (combination 1 g paracetamol/300 mg ibuprofen) in 100 ml solution for infusion is administerd by the attending anaesthetist. Postoperative regular oral Maxegisic (combination 500 mg paracetamol/150 mg ibuprofen), two tablets, every 6 hours is administered by the midwife caring for the participant.. Intervention C: Intraoperative IV 40 mg parecoxib and IV 1 g paracetamol. Postoperative two tablets of Maxigesic, with the first dose being given no less than 12 hours post IV parecoxib
Sponsors
Dr Darren Lowen, Northern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
All women with a singleton pregnancy presenting to The Northern Hospital who have consented to undergo an elective caesarean section
Exclusion criteria
Age < 18 years old Pregnant women who do not have the legal and/or mental capacity to consent Multiple gestation A contraindication to the use of a NSAID (parecoxib or ibuprofen) Women who have signed the study information brochure electing to opt out participation with the McGill Short Form Pain Questionnaire
Outcome results
None listed