Rectal Versus Intramuscular Diclofenac for Pain Relief Following Elective Caesarean Section at Alex Ekwueme Federal University Teaching Hospital Abakaliki: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score after the administration of the rectal and intramuscular diclofenac
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective caesarean section at term with spinal anaesthesia;E
排除标准
- •Allergy to NSAIDS
- •Bleeding diathesis
- •Use of general anesthesia
- •Chronic liver disease
- •History of renal disease
- •Asthma in pregnancy
- •Emergency Cesarean section
- •Morbid obesity
- •Sickle cell anaemia patients
- •Hypertensive disorders of pregnancy
- •Refusal to give consent
研究组 & 干预措施
Rectal diclofenac
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.
干预措施: Rectal Diclofenac (Drug)
Intramuscular diclofenac
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.
干预措施: Intramuscular diclofenac (Drug)
结局指标
主要结局
Pain score after the administration of the rectal and intramuscular diclofenac
时间窗: 24 hours after the last dose
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.
次要结局
- maternal side effects and need for additional analgesia(24 hours after the last dose)
研究者
Assumpta Nnenna Nweke
Principal Investigator
Federal Teaching Hospital Abakaliki