The effect of Apotel and Diclofenac suppository on pain relief after cesarean section among primiparous women: A randomized double-blind clinical trial study

Document Type : Original Article

Authors

1 M.Sc. of Midwifery, Department of Midwifery, School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.

2 Associate Professor, Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

3 PhD in Reproductive Health, Department of Midwifery, School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.

4 M.Sc. of Midwifery, Shirvan Health and Treatment Network, North Khorasan University of Medical Sciences, Bojnord, Iran.

5 M.Sc. of Nursing, Department of Nursing, School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran.

Abstract

Introduction: Inadequate pain control after caesarean can have adverse effects on various body systems, cause the mother not pay attention to the baby and problems in the breastfeeding process. Therefore, the present study was performed with aim to compare Apotel and diclofenac suppository on pain relief after cesarean section.
Methods: This double-blind clinical trial study was performed in 2018 on 120 qualified primiparous women referred to Imam Reza and Pastor Hospitals in Mashhad. The subjects were randomly divided into two groups A and B (Apotel and diclofenac suppository). After cesarean delivery, if the mother requested for pain medication, group A received Apotel and group B diclofenac suppository. The severity of pain was assessed by McGill Pain Questionnaire before intervention, 6, 12 and 24 hours after cesarean section. Data were analyzed by SPSS software (version 16), and Mann-Whitney, t-test, Chi-square and Fisher exact tests. P<0.05 was considered statistically significant.
Results: The two groups had no significant difference in the cesarean pain score before intervention (p=0.214), 6 hours (p=0.318), 12 hours (p=0.305) and 24 hours (p=0.117) after cesarean section. The mean of diclofenac suppository used in group A was 3.21±1.06 and the mean of Apotel used in group B was 1.02±1.22; the two groups were significantly different in the number of Apotel and Diclofenac used (p=0.048).
Conclusion: Although there was no significant difference in the pain scores of the mothers in the Apotel and diclofenac suppository groups, the mean number of diclofenac suppository used was 3 times of Apotel used. Therefore, due to the longer effectiveness of intravenous acetaminophen and its safety compared to diclofenac, Apotel is recommended for cesarean section pain relief.

Keywords


  1. Akhavanakbari G, Entezariasl M, Isazadehfar K, Kahnamoyiagdam F. The effects of indomethacin, diclofenac, and acetaminophen suppository on pain and opioids consumption after cesarean section. Perspectives in clinical research 2013; 4(2):136-41.
  2. Vatankhah M, Sadeghi SE, Zarenezhad M, Rasekh JA, Kalani N, Hatami N, et al. Low doses of propofol and midazolam on maternal hemodynamic symptoms and neonatal Apgar in women undergoing spinal anesthesia in cesarean section: A double-blind randomized clinical trial study. Iran J Obstet Gynecol Infertil 2021; 24(2):41-49.
  3. Abadi TS, Nia MN, Mazlom SR. Effect of self-determination theory-based discharge program on lifestyle and readmission of patients with heart failure: A clinical trial. Evidence Based Care Journal 2020; 10(1):25-35.
  4. Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Practice 2012; 12(5):357-65.
  5. Aradmehr M. Socio-demographic and religious factors affecting fertility rate among childbearing women in Easter Iran: A population-based study. Reproductive Health 2019; 7(1):1553-9.
  6. Maged AM, Deeb WS, Elbaradie S, Elzayat AR, Metwally AA, Hamed M, et al. Comparison of local and intra venous dexamethasone on post operative pain and recovery after caeseream section. A randomized controlled trial. Taiwanese Journal of Obstetrics and Gynecology 2018; 57(3):346-50.
  7. Rafiei M, Ghare MS, Akbari M, Kiani F, Sayehmiri F, Sayehmiri K, et al. Prevalence, causes, and complications of cesarean delivery in Iran: A systematic review and meta-analysis. International journal of reproductive biomedicine 2018; 16(4):221-34.
  8. Kordi M, Irani M, Bahrami HR, Ghaffari SF. Effect of hand and foot massage on vital signs of women after caesarean section. Iran J Obstet Gynecol Infertil 2016; 19(15): 8-15.
  9. Hadizadeh-Talasaz F, Ghoreyshi F, Mohammadzadeh F, Rahmani R. Effect of shared decision making on mode of delivery and decisional conflict and regret in pregnant women with previous cesarean section: a randomized clinical trial. BMC Pregnancy and Childbirth 2021; 21:1-0.
  10. Fattahi Z, Asadpour E, Dehghanpishe L, Karami A, Fakherpour A. Comparing the effects of Acetaminophen, Meperidine, and their combination on postoperative pain management in elective cesarean section. Iran J Obstet Gynecol Infertil 2019; 22(3):1-7.
  11. Shoorab NJ, Mirteimouri M, Taghipour A, Roudsari RL. Women’s experiences of emotional recovery from childbirth-related perineal trauma: a qualitative content analysis. International journal of community based nursing and midwifery 2019; 7(3):181-91.
  12. Zarei MR, Mamashli L, Khachian A, Bozorgnajad M, Mohaddes Ardebili F. The effect of non-pharmacological self-care training on pain control in cesarean section surgery. Journal of Health and Care 2020; 22(1):34-43.
  13. Malekshoar M, Vatankhah M, Rasekh Jahromi A, Ghasemloo H, Mogharab F, Ghaedi M, et al. Shivering control in women under spinal anesthesia: A narrative review on the role of drugs. Iran J Obstet Gynecol Infertil 2021; 24(7):61-9.
  14. Ghasemloo H, Sadeghi SE, Jarineshin H, Rastgarian A, Taheri L, Rasekh Jahromi A, et al. Control of nausea and vomiting in women undergoing cesarean section with spinal anesthesia: A narrative review study on the role of drugs. Iran J Obstet Gynecol Infertil 2021; 24(7):98-107.
  15. Adibi P, Kalani N, Razavi BM, Mehrpour S, Zarei T, Malekshoar M, & et al. Pharmacological and non-pharmacological methods of pain control in women undergoing caesarean section: a narrative review. Iran J Obstet Gynecol Infertil 2022; 25(7):91-112.
  16. Boateng EA, Kumi LO, Diji AK. Nurses and midwives’ experiences of using non-pharmacological interventions for labour pain management: a qualitative study in Ghana. BMC pregnancy and childbirth 2019; 19:1-10.
  17. Kouchek M, Mansouri B, Mokhtari M, Goharani R, Miri MM, Sistanizad M. A comparative study of intravenous paracetamol and fentanyl for pain management in ICU. Iranian Journal of Pharmaceutical Research: IJPR 2013; 12(1):193-8.
  18. Johnson R, Taylor W, De-Vitry Smith S, Bayes S. Skills for Midwifery Practice. 1nd Australia: Elsevier, 2019. P. 558.
  19. Mofidi MA, Shaker HO, Ghafouri H. Comparison of analgesia effect between intravenous propacetamol and tramadol. Journal of Mazandaran University of Medical Sciences 2007; 17(61):81-7.
  20. Zabetian H, Rahmanian M, Tadayon N, Kalani N. Comparison of pain with bupivacaine and bupivacaine-sufentanil combination in women undergoing cesarean section with spinal anesthesia: A double-blind randomized clinical trial. Iran J Obstet Gynecol Infertil 2022; 25(8):8-18.
  21. Talebi H, Kamali A, Hosseini M. Efficacy of intravenous acetaminophen injection on pain intensity and opioid consumption in patients undergoing radius shaft fracture surgery. Anesthesiology and Pain 2014; 5(3):64-72.
  22. Hiller A, Helenius I, Nurmi E, Neuvonen PJ, Kaukonen M, Hartikainen T, et al. Acetaminophen improves analgesia but does not reduce opioid requirement after major spine surgery in children and adolescents. Spine 2012; 37(20):1225-31.
  23. Uysal HY, Takmaz SA, Yaman F, Baltaci B, Başar H. The efficacy of intravenous paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. Journal of clinical anesthesia 2011; 23(1):53-7.
  24. Eray O, Çete YI, Oktay C, Karsli Bİ, Akça S, Cete N, et al. Intravenous single-dose tramadol versus meperidine for pain relief in renal colic. European journal of anaesthesiology 2002; 19(5):368-70.
  25. Jabalameli M, Goudarzi L. Preventive effects of intravenous paracetamol in post-partum pain of elective cesarean delivery with spinal anesthesia. Journal of Isfahan Medical School 2014; 32(296):1227-37.
  26. Navabi Rigi SH, Abedian Z, Poorjavad M, Smaeli H. Comparing the effect of cooling jell pads and ice pack, after episiotomy on the intensity of perineal pain. Tabibe Shargh 2007; 9(1):27-36.
  27. Munishankar B, Fettes P, Moore C, McLeod GA. A double-blind randomised controlled trial of paracetamol, diclofenac or the combination for pain relief after caesarean section. International journal of obstetric anesthesia 2008; 17(1):9-14.
  28. Amrimaleh P, Alijanpour E, Zabihi A, Attarzadeh H, Shirkhani Z, Rezaee B, et al. Comparison of analgesic effect of intravenous paracetamol plus meperidine and meperedine alone on postoperative pain after elective cesarean. Anesthesiology and Pain 2013; 4(3):1-7.
  29. Nourouzi V, Mohammadian A, Isazadehfar K, Rasouli S. Using intravenous acetaminophen in the reduction of opioids in spinal cord surgeries by patient-controlled analgesia. International Surgery Journal 2018; 5(12):3883-7.
  30. Bakhsha F, Niaki AS, Jafari SY, Yousefi Z, Aryaie M. The effects of diclofenac suppository and intravenous acetaminophen and their combination on the severity of postoperative pain in patients undergoing spinal anaesthesia during cesarean section. Journal of clinical and diagnostic research: JCDR 2016; 10(7):UC09.
  31. Uysal HY, Takmaz SA, Yaman F, Baltaci B, Başar H. The efficacy of intravenous paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. Journal of clinical anesthesia 2011; 23(1):53-7.
  32. Altenau B, Crisp CC, Devaiah CG, Lambers DS. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control. American Journal of Obstetrics and Gynecology 2017; 217(3):362-e1.
  33. Ghorayshi F, Hadizadeh Talasaz F, Rahmani R, Ahmadi H, Mohammadzadeh F. The effect of shared decision making on anxiety and satisfaction of decision about mode of delivery in pregnant women with a history of previous cesarean section: a randomized clinical trial. Journal of Midwifery and Reproductive Health 2022; 10(2):3229-39.
  34. Aradmehr M, Azhari SE, Ahmadi S, Azmodeh EL. Relationship between delivery and neonatal factors with healing of episiotomy in primiparous women at Mashhad Omalbanin hospital in 2013. Iran J Obstet Gynecol Infertil 2016; 19(17):13-23.