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The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator |
| |
| Acetaminophen/Ibuprofen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | 1g acetaminophen is administered during skin closure (end of operation). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Obstetric QoR-11K score 24 hours after end of surgery | Minimum 0, poor recovery; maximum 110, good recovery | 24 hours after end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale pain score (0-10) 4 hours after end of surgery | 0, no pain; 10, worst pain imaginable | 4 hours after end of surgery |
| Numeric rating scale pain score (0-10) 8 hours after end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hansol Kim, MD | Contact | +82-10-3160-1548 | hansolfrkr@gmail.com | |
| Junghwa Seo, MD, PhD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Acetaminophen/Ibuprofen | Drug | A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation) |
|
|
| Acetaminophen | Drug | 1g acetaminophen is administered 6 hours after the first administration. |
|
|
| Acetaminophen/Ibuprofen | Drug | A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration. |
|
|
0, no pain; 10, worst pain imaginable
| 8 hours after end of surgery |
| Numeric rating scale pain score (0-10) 12 hours after end of surgery | 0, no pain; 10, worst pain imaginable | 12 hours after end of surgery |
| Numeric rating scale pain score (0-10) 24 h after end of surgery | 24 h after end of surgery |
| Numeric rating scale pain score (0-10) 48 hours after end of surgery | 0, no pain; 10, worst pain imaginable | 48 hours after end of surgery |
| Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery | 24 h after end of surgery |
| Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery | 48 h after end of surgery |
| Use of rescue analgesia during the first 24 hours after end of surgery | 24 h after end of surgery |
| Use of rescue analgesia during the first 48 hours after end of surgery | 48 h after end of surgery |
| Wound-related complications during hospital stay, up to 5 days | From end of surgery to patient discharge, up to 5 days |
| Operation time | Duration of operation |
| Anesthesia time | Duration of anesthesia |
| Injection level of intrathecal drug | After arrival at the operating room |
| Dosage of intrathecal drug (mg, bupivacaine) | After arrival at the operating room |
| Sensory blockade level by time point | 0, 5, 10 minutes after intrathecal injection and at the end of operation |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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