Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period
- Registration Number
- NCT04653506
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 107
- Women between the ages of 18-50, who gave birth in a vaginal birth
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibuprofen group Ibuprofen 400 mg Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg) Paracetamol group Paracetamol 1000 mg Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg)
- Primary Outcome Measures
Name Time Method Pain relief after treatment with Paracetamol or Ibuprofen 6 hours after intervention 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).
- Secondary Outcome Measures
Name Time Method Maximum pain location 6 hours after intervention 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)
Trial Locations
- Locations (1)
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel