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Randomised Controlled Trial of Cox-2 Selective versus Non-selective Non-Steroidal Anti-Inflammatory Drugs for Postoperative Analgesia in Caesarean Sections

Randomised Controlled Trial of Cox-2 Selective versus Non-selective Non-Steroidal Anti-Inflammatory Drugs for Postoperative Analgesia in Caesarean Sections

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000287235
Acronym
PARIBU
Enrollment
200
Registered
2018-02-23
Start date
2018-05-07
Completion date
2020-05-07
Last updated
2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Caesarean Section is a procedure commonly performed in Australia and worldwide. In Western Australia 34% of deliveries are performed by caesarean section. The procedure is performed under neuraxial anaesthesia for 98% of procedures in Western Australia. Pain following caesarean section is common with majority of patients requiring opiate analgesia. Despite being a procedure that is performed commonly there is a wide variety of both intraoperative and postoperative analgesia regimes. There has been conflicting evidence of the value of giving non-steroidal anti-inflammatory drugs (NSAIDs) on reducing post-operative analgesia requirements and whether non-selective NSAIDs are more effective than selective NSAIDs. The study will randomise the patient to receive either a non-selective or selective NSAID and assess whether there is any difference in pain scores. The null hypothesis is that there will be no difference in pain scores in the treatment groups.

Interventions

The patient will randomised to one of two treatment groups. The intervention group and the active control group. Intervention Post delivery of baby, 800 mg ibuprofen diluted in 250 ml normal saline given intravenously over 30 minutes. Oral ibuprofen will be started 12 hours after at 400mg twice daily per orally. This will be continued for 3 days. Adherence will be monitored to ensure that the medication was given in theatre and medication will be charted in drug chart. If patient is not admi

The patient will randomised to one of two treatment groups. The intervention group and the active control group. Intervention Post delivery of baby, 800 mg ibuprofen diluted in 250 ml normal saline given intravenously over 30 minutes. Oral ibuprofen will be started 12 hours after at 400mg twice daily per orally. This will be continued for 3 days. Adherence will be monitored to ensure that the medication was given in theatre and medication will be charted in drug chart. If patient is not administered medication or it is refused it will be recorded. The doses are predetermined doses and will be blinded to patient and staff.

Sponsors

Dr Gareth Ansell
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Patients having elective category 4 caesarean sections

Exclusion criteria

Allergy or contraindications to non-steroidal anti-inflammatory drugs abnormal placentation peptic ulcer coagulopathy pre-eclampsia renal dysfunction patient refusal

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026