Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2020-06-01
2022-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Fixed time interval group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. 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).
Paracetamol 1000 Mg Oral Tablet
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
Ibuprofen 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.
MIR
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).
'On-demand' group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. 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).
Paracetamol 1000 Mg Oral Tablet
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
Ibuprofen 400 mg
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
MIR
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).
Interventions
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Paracetamol 1000 Mg Oral Tablet
The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
Ibuprofen 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.
Paracetamol 1000 Mg Oral Tablet
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
Ibuprofen 400 mg
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
MIR
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Women with chronic pain syndrome.
3. Women with relative or absolute contraindications for paracetamol or NSAIDs.
18 Years
45 Years
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Gal Bachar MD
Principal investigator
Principal Investigators
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Gal Bachar, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Medical Health Center
Locations
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Rambam
Ramat Yishai, , Israel
Countries
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References
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Bachar G, Alter A, Justman N, Buchnik Fater G, Farago N, Ben-David C, Abu-Rass H, Siegler Y, Hajaj A, Landau-Levin M, Zipori Y, Khatib N, Weiner Z, Vitner D. Fixed-time interval vs on-demand oral analgesia after vaginal delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 May;6(5):101372. doi: 10.1016/j.ajogmf.2024.101372. Epub 2024 Apr 5.
Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
Other Identifiers
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Rambam Health Care Center.
Identifier Type: -
Identifier Source: org_study_id
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