Comparing Protocols for Analgesia Following Elective Cesarean Section
NCT ID: NCT03622489
Last Updated: 2018-08-09
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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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2017-03-01
2018-08-31
Brief Summary
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1. Scheduled doses of IV acetaminophen + PO Ibuprofen
2. Scheduled doses of PO acetaminophen + PO Ibuprofen
3. "On demand" doses of acetaminophen, dipyrone and ibuprofen.
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Detailed Description
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Exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
Number of participants: 120
Treatment:
All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS\>3
2. IV Tramal 100 mg, once
After Admitted to Mternity ward:
* 1st group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr
* 2nd group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr
* 1st+2nd group will be given additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS\>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS\>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses.
\- 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:
* Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses.
* PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses.
* Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tab ibuprofen + IV acetaminophen
All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS\>3
2. IV Tramal 100 mg, once
After Admitted to Maternity ward:
\- Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr
-Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS\>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS\>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses.
Acetaminophen
mentioned above
Ibuprofen 400 mg
mentioned above
Tramadol
mentioned above
Morphine
mentioned above
Tramal
mentioned above
Tab Ibuprofen + Tab acetaminophen
All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS\>3
2. IV Tramal 100 mg, once
After Admitted to Maternity ward:
\- Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr
\- Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS\>4, up to 4 times a day, at least 6 hours between doses.
Tab Tramadex 100 mg, for VNS\>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses.
Acetaminophen
mentioned above
Ibuprofen 400 mg
mentioned above
Tramadol
mentioned above
Morphine
mentioned above
Tramal
mentioned above
"On demand" analgesia
All women will receive immediately after surgery, in the recovery room:
1. IV morphin 5 mg, repeat doses every 10 minutes for VNS\>3
2. IV Tramal 100 mg, once
After Admitted to Mternity ward:
Will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:
* Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses.
* PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses.
* Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.
Acetaminophen
mentioned above
Ibuprofen 400 mg
mentioned above
Dipyrone
mentioned above
Tramadol
mentioned above
Morphine
mentioned above
Tramal
mentioned above
Interventions
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Acetaminophen
mentioned above
Ibuprofen 400 mg
mentioned above
Dipyrone
mentioned above
Tramadol
mentioned above
Morphine
mentioned above
Tramal
mentioned above
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
45 Years
FEMALE
Yes
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Michal Kovo, MD
Role: STUDY_CHAIR
Wolfson Medical Center
Locations
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Wolfson medical center
Holon, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Dafna L, Herman HG, Ben-Zvi M, Bustan M, Sasson L, Bar J, Kovo M. Comparison of 3 protocols for analgesia control after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 May;1(2):112-118. doi: 10.1016/j.ajogmf.2019.04.002. Epub 2019 Apr 8.
Other Identifiers
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0022-17-WOMC
Identifier Type: -
Identifier Source: org_study_id
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