An interventional study of Piroxicam group and Diclofenac group in Analgesia and Post Caserean, sponsored by Federal Teaching Hospital Abakaliki. Completed at 1 site in Nigeria. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Federal Teaching Hospital Abakaliki · Not applicable, Interventional, and Supportive care
Multimodal analgesic combination of pentazocine-diclofenac has been found to be superior to pentazocine-piroxicam and was associated with a higher level of maternal satisfaction. our study aims to determine the efficacy of piroxicam when compared with diclofenac as pain relief post caesarean section.
ABSTRACT Background: Postoperative pain is unavoidable after caesarean section. It constitutes a big challenge to patient's recovery and maternal-infant bonding. The importance of adequate pain control cannot be over emphasized but there is no gold standard for post caesarean section analgesia. A multimodal approach to post caesarean section pain control has been shown to enhance analgesia and reduce side effects but the right combination of analgesics is yet to be determined.
Objective: To compare the efficacy of Pentazocine and Piroxicam versus Pentazocine and Diclofenac for post caesarean section analgesia within first 24 hours.
Method: Eligible participants undergoingelective caesarean section atAlex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and St Patrick's Mile 4 Hospital Abakaliki were randomized into two groups, A and B, of 54 participants each using computer generated list of random numbers. Group A receiveda single dose of intramuscular Piroxicam 20mg, while group B received two doses of intramuscular Diclofenac 75mg given 12 hours apart. Participants in both groups also received intramuscular Pentazocine 30mg 6 hourly for 24 hours. The first dose of the drugs was administered immediately after skin closure. The primary outcome measure was control of postoperative painwithin the first 24 hours after caesarean section assessed using visual analogue scale, while the secondary outcome measures were the maternal drug side effects (epigastric pain, nausea etc) and participants' satisfaction. Data obtained was entered into a predesigned sheet and analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). A difference with a p-value \<0.05 was considered statistically significant.
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Group A received a single dose of intramuscular Piroxicam 20 mg.The first dose was administered immediately after skin closure. Thereafter, this group received intramuscular Pentazocine 30mg 6 hourly for 24 hours.
Drug: Piroxicam group
Group B received two doses of intramuscular diclofenac 75 mg.The first dose was administered immediately after skin closure and the second dose was administered 12 hours after the first dose. intramuscular Pentazocine 30mg was given 6 hourly for 24 hours.
Drug: Diclofenac group
Experimental drug
Active drug
Postoperative pain
This is the post operative pain within the first 24 hours
Time frame: 24 hours
Plan to share: No — This will be following publication
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Federal Teaching Hospital Abakaliki