Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

Tel Aviv Sourasky Medical Center

Status: Completed

Conditions: Pain

Treatments: Drug: Paracetamol 1000 mg; Drug: Ibuprofen 400 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04653506

0368-20-TLV

Details and patient eligibility

About

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

Full 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.

Enrollment: 107 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

Paracetamol group

Experimental group

Description:

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

Treatment:

Drug: Paracetamol 1000 mg

Ibuprofen group

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen 400 mg