Not Yet RecruitingPhase 4ACTRN12618000287235

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


Sponsor

Dr Gareth Ansell

Enrollment

200 participants

Start Date

May 7, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • Patients having elective category 4 caesarean sections

Exclusion Criteria7

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

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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 salin

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.


Locations(1)

King Edward Memorial Hospital - Subiaco

WA, Australia

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