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| Name | Class |
|---|---|
| Kyongbo Pharmaceutical | UNKNOWN |
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This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.
Adult patients undergoing elective unilateral VATS wedge resection, segmentectomy, or lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=48) or not (n=48). At the end of induction, the intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. The control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxigesic group | Experimental | At the end of induction, the Maxigesic group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. |
|
| Control group | Placebo Comparator | At the end of induction, the control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen/ibuprofen fixed-dose combination | Drug | Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption during 24 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 6, 48 hours |
| Postoperative pain score | 11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hojin Lee, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | KS013 | South Korea |
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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 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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A prospective randomized double-blinded study
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The nurse who is not involved in this study knows the allocated group and sends the bottle of the drug which looks the same in both groups, to the operation room and ward.
The care provider, investigator, patients, and outcomes assessor will be not informed of the infusion of the drug by not attaching an identifiable label so that it cannot be distinguished from normal saline.
| Saline | Drug | 100 ml of normal saline |
|
|
| postoperative 6, 24, 48 hours |
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (%) | postoperative 24, 48 hours |
| Quality of recovery-15 | Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery" | postoperative 24, 48 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |