Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period
NCT ID: NCT04653506
Last Updated: 2024-02-20
Study Results
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Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2020-11-28
2023-07-06
Brief Summary
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Detailed Description
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This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia.
The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6).
The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not.
Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Pain Reliefs will be given in a double-blind mechanism, in closed envelopes
* The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg
* Women participating in the study will answer a questionnaire to characterize the pain while taking the pain relief (time 0), an hour later (time 1), 4 and 6 hours later (time 4 and time 6)
TREATMENT
DOUBLE
Study Groups
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Paracetamol group
Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg)
Paracetamol 1000 mg
Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
Ibuprofen group
Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg)
Ibuprofen 400 mg
Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
Interventions
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Paracetamol 1000 mg
Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
Ibuprofen 400 mg
Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* After cesarean section
* Received analgesia prior to study recruitment
* Perineal tears grade 3 \\ 4
* Women with chronic pain, rheumatic disease, fibromyalgia, or trauma
* Women with a diagnosis or medication for anxiety or depression
* Dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in NICU exceeding one week
18 Years
50 Years
FEMALE
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Shmuel Kivity, MD
director head of clinical trails department, principal investigator, clinical professor
Principal Investigators
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shai ram, MD
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center
Locations
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Tel Aviv Medical Center
Tel Aviv, , Israel
Countries
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References
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Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
Fahey JO. Best Practices in Management of Postpartum Pain. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):126-136. doi: 10.1097/JPN.0000000000000241.
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
Deussen AR, Ashwood P, Martis R. Analgesia for relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2011 May 11;(5):CD004908. doi: 10.1002/14651858.CD004908.pub2.
Wuytack F, Smith V, Cleary BJ. Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2016 Jul 14;7(7):CD011352. doi: 10.1002/14651858.CD011352.pub2.
Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002.
Chou D, Abalos E, Gyte GM, Gulmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2.
Ram S, Madar D, Ram HS, Peleg G, Lior Y, Greenfeld A, Yakov G, Yogev Y, Maslovitz S. Paracetamol versus ibuprofen for early postpartum pain control: a randomized controlled trial. Arch Gynecol Obstet. 2025 Jul;312(1):51-57. doi: 10.1007/s00404-024-07797-4. Epub 2024 Nov 5.
Other Identifiers
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0368-20-TLV
Identifier Type: -
Identifier Source: org_study_id
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