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Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding.
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fix protocol - Oral treatment | Experimental | During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication): At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams). After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams. Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day. The total amount of paracetamol is limited to 4 gr per day. |
|
| Spinal morphine | Experimental | The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol hydrochloride | Drug | Please see arm description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of pain management | Pain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain | during 48 hours from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Each patient will fill in a satisfaction questioner which is given 48 hours after surgery | 48 hours after surgery |
| The necessity of additional medications (rescue doses) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Medical Center | Afula | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34463805 | Derived | Yefet E, Nassar S, Carmeli J, Massalha M, Hasanein J, Zafran N, Rudin M, Nachum Z. Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial. Arch Gynecol Obstet. 2022 Apr;305(4):893-901. doi: 10.1007/s00404-021-06196-3. Epub 2021 Aug 31. |
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| Morphine |
| Drug |
Please see arm description |
|
| Paracetamol | Drug |
|
| Diclofenac | Drug |
|
| TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG) | Drug |
|
| During 48 hours after surgery |
| Adverse effect of the medications given in each protocol on the mother and neonates | during 48 hours following surgery |
| To compare the amount of breastfeeding between 2 groups | Following the week after surgery |
| Total amount of pain medications required in each study group | during 48 hours following surgery and after 7 days |
| The efficacy of pain management during 4 days past surgery | Pain sensation will be assessed using the VAS scale | during 4 days past surgery |
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D009020 | Morphine |
| D000082 | Acetaminophen |
| D004008 | Diclofenac |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D003061 | Codeine |
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