NCT04653506

Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2020-11-28
• Primary completion: 2022-07-01
• Completion: 2023-07-06
• First posted: 2020-12-04
• Last updated: 2024-02-20

Locations

1 site across 1 country: Israel