Pain
Conditions
Keywords
Post Partum Pain, Pain Relief, Non-Opioids Analgesia
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.
Interventions
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
DRUGIbuprofen 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
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The primary investigator will be the only one to have the information about envelopes contain
Intervention model description
* Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS \<3) * Pain Reliefs will be given in a double-blind mechanism, in closed envelopes * The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg * 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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect on breastfeeding | 6 hours after intervention | The participants will answer a questionnaire that will describe the effect of' pain relief on a woman's ability to breastfeed. The questionnaire will ask their desire to breastfeed before giving birth, did they really manage to breastfeed, and when they started breastfeeding. The investigator will describe if there is a correlation between pain relief and the ability to breastfeed. |
Countries
Israel
Outcome results
None listed