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Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia:
A prospective randomised trial. Women undergoing elective cesarean section will be randomized to three groups. The treatment will be given for 48 hours after surgery. For evealuating objective pain sensation the investigators will be using the Visual Numerical Score (VNS). Demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores.
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:
After Admitted to Mternity ward:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tab ibuprofen + IV acetaminophen | Experimental | All women will receive immediately after surgery, in the recovery room:
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. |
|
| Tab Ibuprofen + Tab acetaminophen | Experimental | All women will receive immediately after surgery, in the recovery room:
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. |
|
| "On demand" analgesia | Experimental | All women will receive immediately after surgery, in the recovery room:
After Admitted to Mternity ward: Will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | mentioned above |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average pain score 48 hours following surgery: visual numerical scale (VNS) | Using : visual numerical scale (VNS) | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lotem Dafna, MD | Contact | +972524205415 | lotemdafne@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Michal Kovo, MD | Wolfson Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson medical center | Recruiting | Holon | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33345816 | Derived | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D004177 | Dipyrone |
| D014147 | Tramadol |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Ibuprofen 400 mg | Drug | mentioned above |
|
| Dipyrone | Drug | mentioned above |
|
| Tramadol | Drug | mentioned above |
|
|
| Morphine | Drug | mentioned above |
|
| Tramal | Drug | mentioned above |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |