None listed
Conditions
Brief summary
The CROPP trial evaluates the hypothesis that 2 drug regimens are equally effective to deliver pain relief after a caesarean section. The drug which we are testing is called Oxycodone. We deliver the Oxycodone to participants in the test group in controlled release form on a regular basis over 2 days. The participant is also able to request immediate release Oxycodone for the breakthrough pain. These tablets are swallowed with water. In the control group the participants will receive Morphine into a vein each time a computer called a Patient controlled analgesic device is activated by the participant. The primary aim of the research project is to see if the 2 types of drugs have the same ability to relieve pain. The secondary aims are to see if these 2 drugs have the same safety profile, nausea, vomiting and pruritis incidence and if patients in both groups are equally satisfied with their treatment.
Interventions
Oral opioid analgesia post ceasarean section in the form of Controlled release Oxycodone 20mg twice daily for a maximum of 4 doses over a period of 48 hours, with Oxycodone immediate release 10 to 15mg orally at a minimum interval of 3 hours between doses as needed over a period of 48 hours post partum.
Drug charts are monitored to monitor drug use over the mentioned period.
Both test and control group will receive additional analgesia in the form of Paracetamol 1 gram oral, Ibuprofen 400mg
Oral opioid analgesia post ceasarean section in the form of Controlled release Oxycodone 20mg twice daily for a maximum of 4 doses over a period of 48 hours, with Oxycodone immediate release 10 to 15mg orally at a minimum interval of 3 hours between doses as needed over a period of 48 hours post partum. Drug charts are monitored to monitor drug use over the mentioned period. Both test and control group will receive additional analgesia in the form of Paracetamol 1 gram oral, Ibuprofen 400mg regularly. Tramadol 50 - 100mg IV or oral is available as a rescue medication in case of poor pain control despite maximum use of the trial regimen. The anaesthetic for the caesarean section is standardised to a single shot spinal anaesthetic with a combination of Heavy Bupivavaine 0.5% and Fentanyl 15 - 25mcg, Paracetamol 1g and Diclofenac 100mg PR
Sponsors
Dr. Petrus J Kotze
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Elective ceasarean section patients Spinal anaesthetic for caesarean section No contraindication to use trial medication Able to consent
Exclusion criteria
General anaesthesia Contraindication to trial medication Unable to consent
Outcome results
None listed