Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

NCT04653506 | Completed

• 1 other identifier: 0368-20-TLV
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period

Conditions

Pain

Keywords

Post Partum Pain, Pain Relief, Non-Opioids Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Maximum pain location

  6 hours after intervention

Other Outcomes (1)

• Effect on breastfeeding

  6 hours after intervention

Study Arms (2)

Paracetamol group

EXPERIMENTAL

Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg)

Drug: Paracetamol 1000 mg

Ibuprofen group

EXPERIMENTAL

Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg)

Drug: Ibuprofen 400 mg

Interventions

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

Paracetamol group

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

Ibuprofen group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Postpartum women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 18-50, who gave birth in a vaginal birth

You may not qualify if:

• Sensitivity to Paracetamol or Ibuprofen
• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

Location

Related Publications (9)

• 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.

  PMID: 15507941 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.

  PMID: 28277399 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.

  PMID: 18818022 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.

  PMID: 31348508 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.

  PMID: 21563142 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.

  PMID: 27412362 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.

  PMID: 9515184 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.

  PMID: 23440827 BACKGROUND

• 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.

  PMID: 39499309 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• shai ram, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The primary investigator will be the only one to have the information about envelopes contain
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director head of clinical trails department, principal investigator, clinical professor

Model Details: * Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS \<3) * 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)

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 4, 2020
• Study Start: November 28, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 6, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)