Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia
| Autor: | Shu-Wen Jao, Yi-Hung Kuo, Wen-Shih Huang, Hong-Hwa Chen, Chung-Wei Fan, Chien-Yuh Yeh, Chang-Chieh Wu, Tian-Yuh Liou, Jeng-Yi Wang, Jinn-Shiun Chen, Wen-Ko Tseng, Ko-Chao Lee, Meng-Chiao Hsieh, Hsi-Hsiung Chiu, Pao-Shiu Hsieh, Chia-Cheng Lee, Yuan-Chiang Chung |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Hemorrhoidectomy Male medicine.medical_specialty Treatment outcome Taiwan Placebo-controlled study Nalbuphine Injections Intramuscular Double blind 03 medical and health sciences 0302 clinical medicine Double-Blind Method 030202 anesthesiology Sebacoyl dinalbuphine ester Preoperative Care medicine Humans Pain Measurement Pain Postoperative business.industry Surgery Analgesics Opioid Treatment Outcome Anesthesiology and Pain Medicine Long acting Patient Satisfaction Area Under Curve Delayed-Action Preparations Anesthesia Female Neurology (clinical) Extended release Opioid analgesics business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | The Clinical Journal of Pain. 33:429-434 |
| ISSN: | 0749-8047 |
| DOI: | 10.1097/ajp.0000000000000417 |
| Popis: | This study was conducted to evaluate the safety and efficacy of single sebacoyl dinalbuphine ester (SDE) injection (150 mg/2 mL) when administered intramuscularly to patients who underwent hemorrhoidectomy for postoperative long-acting analgesia.A total of 221 patients scheduled for hemorrhoidectomy from 6 centers in Taiwan were randomly divided into SDE group and placebo group, and received the treatment, vehicle or SDE, 1 day before the surgery. Visual analogue scale (VAS) was recorded up to 7 to 10 days. Pain intensity using VAS AUC through 48 hours after surgery was calculated as the primary efficacy endpoint.Area under the curve of VAS pain intensity scores (VAS AUC) through 48 hours after hemorrhoidectomy was significantly less in SDE group than those in placebo group (209.93 vs. 253.53). VAS AUC from the end of surgical procedure to day 7 was also significantly different between SDE and placebo group (630.79 vs. 749.94). SDE group consumed significantly less amount of other analgesics, such as PCA ketorolac and oral ketorolac. Median time from the end of surgery to the first use of pain relief medication was also shortened in the placebo group than in the SDE group. Most adverse events were assessed as mild and tolerable in both groups.SDE injection demonstrated an extended analgesia effect, with a statistically significant reduction in pain intensity through 48 hours and 7 days after hemorrhoidectomy. |
| Databáze: | OpenAIRE |
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