Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

Tel-Aviv Sourasky Medical Center107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

107

Conditions

Pain

Interventions

Paracetamol 1000 mgDRUG

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 mgDRUG

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

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women between the ages of 18-50, who gave birth in a vaginal birth 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

Locations (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

Pain relief after treatment with Paracetamol or Ibuprofen

Time frame: 6 hours after intervention

Secondary Outcomes

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)

Time frame: 6 hours after intervention

Data from ClinicalTrials.gov

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