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Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.
Background: Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.
Aim: This study is designed to compare the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital, Abakaliki.
Methods: This was a randomized equivalence controlled trial conducted among pregnant women booked for elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital Abakaliki, comparing the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective caesarean section at term. One arm received 100mg of suppository diclofenac and the other arm received 75mg of intramuscular diclofenac. These doses were repeated every 12hours for 24 hours. Pain scoring was done at 1, 6, 12, 18 and 24 hours after administration of the drugs. The data obtained was analysed using IBM SPSS software (version 23, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal diclofenac | Experimental | Participants had 100mg of rectal diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours. |
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| Intramuscular diclofenac | Active Comparator | Participants had 75mg of intramuscular diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Diclofenac | Drug | Rectal diclofenac, 100mg administered immediately after skin closure then 12 hourly for 24 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain score after the administration of the rectal and intramuscular diclofenac | Pain score at different intervals with either rectal or intramuscular diclofenac immediately after skin closure. This pain assessment was done with visual analogue scale ranging from 0 to 10. zero represents no pai while ten represents the worst possible pain. | 24 hours after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| maternal side effects and need for additional analgesia | Number of participants with local irritation at the site of injection or insertion of drug,headache,dizziness and loss of appetite. a Also the number of participants requiring additional analgesia | 24 hours after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
Post caesarean section
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alex Ekwueme Federal University Teaching Hospital | Abakaliki | Ebonyi State | 480101 | Nigeria |
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open label randomized controlled trial
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| Intramuscular diclofenac | Drug | Intramuscular diclofenac, 7mg administered immediately after skin closure then 12 hourly for 24 hours. |
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