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The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period
Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol group | Experimental | Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg) |
|
| Ibuprofen group | Experimental | Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol 1000 mg | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief after treatment with Paracetamol or Ibuprofen | After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The pain rating will be on the Numeric Rating Scale (NRS) that labeled from zero (no pain) to ten ((worst pain). | 6 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain location | After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The questionnaire will describe the maximal pain location area and the effectiveness of analgesic treatment in this area (by rating the pain on the NRS). The questionnaire will be at the time of taking the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on breastfeeding | The participants will answer a questionnaire that will describe the effect of' pain relief on a woman's ability to breastfeed. The questionnaire will ask their desire to breastfeed before giving birth, did they really manage to breastfeed, and when they started breastfeeding. The investigator will describe if there is a correlation between pain relief and the ability to breastfeed. |
Inclusion Criteria:
Exclusion Criteria:
Postpartum women
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| Name | Affiliation | Role |
|---|---|---|
| shai ram, MD | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Medical Center | Tel Aviv | 6423906 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15507941 | Background | 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. | |
| 28277399 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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The primary investigator will be the only one to have the information about envelopes contain
| Ibuprofen 400 mg | Drug | 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 |
|
| 6 hours after intervention |
| 6 hours after intervention |
| 18818022 | Background | 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. |
| 31348508 | Background | 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. |
| 21563142 | Background | 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. |
| 27412362 | Background | 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. |
| 9515184 | Background | Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002. |
| 23440827 | Background | 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. |
| 39499309 | Derived | 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. |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |