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

0368-20-TLV

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

2020-11-28

2022-07-01

2023-07-06

Completed

107

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS \\<3)\n* Pain Reliefs will be given in a double-blind mechanism, in closed envelopes\n* The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg\n* Women participating in the study will answer a questionnaire to characterize the pain while taking the pain relief (time 0), an hour later (time 1), 4 and 6 hours later (time 4 and time 6)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The primary investigator will be the only one to have the information about envelopes contain', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 107, 'type': 'ACTUAL'}}

2024-02-20