Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

Last updated: February 18, 2024
Sponsor: Tel-Aviv Sourasky Medical Center
Overall Status: Completed

Phase

N/A

Condition

Pain

Treatment

Paracetamol 1000 mg

Ibuprofen 400 mg

Clinical Study ID

NCT04653506
0368-20-TLV
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 107
Treatment Group(s): 2
Primary Treatment: Paracetamol 1000 mg
Phase:
Study Start date:
November 28, 2020
Estimated Completion Date:
July 06, 2023

Study Description

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.

Connect with a study center

  • Tel Aviv Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

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