Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement. A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine). In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
Rambam
Ramat Yishai, Israel
Visual analog scale (VAS) score difference in the 24 first hours.
Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
Time frame: In the first 24 hours postpartum.
Amount of additional analgesia requirements.
Total amount of additional analgesia up to maternal discharge.
Time frame: Up to maternal discharge (5 days)
Total analgesia requirements.
Total amount of analgesics use during 48 hours following a vaginal delivery.
Time frame: Up to 48 hours postpartum.
Breastfeeding rate.
The rate of women who breastfeed their newborns and breastfeeding frequency.
Time frame: Up to 48 hours postpartum.
Treatments side effects.
Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.
Time frame: Up to 48 hours postpartum.
Visual analog scale (VAS) score difference up to maternal discharge.
Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
Time frame: At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). up to 5 days.
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The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).