Breast Feeding, Opioid Use, Pain, Post Partum Depression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
DRUGIbuprofen 400Mg Tab
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
DRUGIbuprofen 400 mg
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
DRUGMIR
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).
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented. All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1\. Women following term vaginal delivery.
Exclusion criteria
1. Under Age 18 years or older than 45 years. 2. Women with chronic pain syndrome. 3. Women with relative or absolute contraindications for paracetamol or NSAIDs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) score difference in the 24 first hours. | In the first 24 hours postpartum. | Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total analgesia requirements. | Up to 48 hours postpartum. | Total amount of analgesics use during 48 hours following a vaginal delivery. |
| Amount of additional analgesia requirements. | Up to maternal discharge (5 days) | Total amount of additional analgesia up to maternal discharge. |
| Breastfeeding rate. | Up to 48 hours postpartum. | The rate of women who breastfeed their newborns and breastfeeding frequency. |
| Treatments side effects. | Up to 48 hours postpartum. | Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia. |
| Visual analog scale (VAS) score difference up to maternal discharge. | 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. | Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction). |
Countries
Israel
Outcome results
None listed