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Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Optimal pain control post-caesarean section will benefit not only the mother and her baby, but also a healthcare system. Optimal pain control may shorten the time spent in hospital after caesarean section and, therefore, reduce healthcare costs.
Pain after cesarean section (CS), usually described as strong, is an obstacle to good mother-child interaction and post-operative rehabilitation. Its management is important for a quick recovery and allow the mother to take care and link with her newborn. Currently, intrathecal opioids are the most commonly used technique and provide the foundation for post-cesarean analgesia. This technique combined with multimodal analgesia reduces the doses of morphine consumed, including these side effects. Spinal anesthesia is the standard anesthetic technique for caesarean section; it offers several advantages including the possibility of prescribing oral analgesics. An ideal analgesic protocol is one that is simple to implement, cost-effective, and has minimal impact on the work staff. It would have a good safety profile, a low incidence of side effects and complications, and respond to wide inter-patient variability. It relieves the mother of high quality pain while having minimal interference with her, newborn care and anesthesia while allowing safe breastfeeding.
The aim of this work is to compare the quality of an multimodal oral analgesia with intravenous analgesia and to demonstrate non-inferiority of the oral route pain relieve in postoperative caesarean section period. The secondary objectives was to evaluate the maternal tolerance of the drugs (piroxicam, nefopam, paracetamol) used postoperatively of a caesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Group | Active Comparator | received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) |
|
| Intravenous group | Active Comparator | received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefopam 20 MG/ML | Drug | given by Oral route the dose of 20mg every 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) pain | from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at rest and coughing or mobilization | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| morphine consumption | morphine consumption | 24 hours postoperative |
| sides effects | the occurrence of any undesirable effects related to the administration of any of the 3 drugs (nausea, vomiting, diarrhea, malaise, hypotension, sweating, convulsion, dryness of the mouth, tachycardia, palpitations, vertigo, allergic reactions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Maternité de Monastir | Monastir | 5000 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28928554 | Background | Mahajan L, Mittal V, Gupta R, Chhabra H, Vidhan J, Kaur A. Study to Compare the Effect of Oral, Rectal, and Intravenous Infusion of Paracetamol for Postoperative Analgesia in Women Undergoing Cesarean Section Under Spinal Anesthesia. Anesth Essays Res. 2017 Jul-Sep;11(3):594-598. doi: 10.4103/0259-1162.206872. | |
| 25821010 | Background |
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| "Nefopam (Acupan)" 20 MG/ML Injectable Solution | Drug | given by intravenous route at the dose of 20mg every 6 hours. |
|
|
| "Acetaminophen, (paracetamol)" 500Mg Tab | Drug | 2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours. |
|
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| (Acetaminophen "paracetamol") IV Soln 10 MG/ML | Drug | Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours. |
|
|
| (Piroxicam "piroxan") 20 MG Oral Tablet | Drug | 2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours. |
|
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| (Piroxicam "piroxan") 20Mg/1mL Injection | Drug | 2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours. |
|
|
| 24 hours postoperative |
| postoperative complications | The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc). | 24 hours post operative |
| Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009340 | Nefopam |
| D000082 | Acetaminophen |
| D013607 | Tablets |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010079 | Oxazocines |
| D001392 | Azocines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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