Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain
关键词
抽象
描述
72 ASA I-II patients between 3 and 12 years of age who scheduled to undergo tonsillectomy were enrolled in this randomized, prospective and placebo-controlled study. The indications for tonsillectomy were recurrent infections and tonsillar hypertrophy leading to obstructive symptoms.
The patients included to the study were randomly assigned to one of the 3 groups to receive different concentrations of levobupivacaine or saline.
The mean arterial pressure (MAP) and heart rates (HR) of all patients were recorded during the whole anesthesia and surgical procedures. The duration of anesthesia and surgery were also recorded. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour.
日期
| 最后验证: | 11/30/2014 |
| 首次提交: | 12/12/2014 |
| 提交的预估入学人数: | 12/21/2014 |
| 首次发布: | 12/22/2014 |
| 上次提交的更新: | 12/21/2014 |
| 最近更新发布: | 12/22/2014 |
| 实际学习开始日期: | 07/31/2008 |
| 预计主要完成日期: | 11/30/2008 |
| 预计完成日期: | 11/30/2008 |
状况或疾病
干预/治疗
Other: Group S
Drug: Group LL
Drug: Group HL
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Group S Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline | Other: Group S Peritonsillar infiltration with saline Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour. |
| Active Comparator: Group LL Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil). | Drug: Group LL Peritonsillar infiltration with low-dose of levobupivacaine 0.25%. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour. |
| Active Comparator: Group HL Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil). | Drug: Group HL Peritonsillar infiltration with high dose of levobupivacaine 0.5%. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour. |
资格标准
| 有资格学习的年龄 | 3 Years 至 3 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to recurrent infections leading to obstructive symptoms - Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to tonsillar hypertrophy leading to obstructive symptoms. Exclusion Criteria: - Hypersensitivity to sevoflurane, benzodiazepine, fentanyl analogues, propofol and components, paracetamol, levobupivacaine - Presence of coagulation disorders and chronic diseases - Presence of regular use of analgesics - Presence of analgesic use within 24 hours prior to surgery - Presence of upper respiratory system infection - Inability to understand the pain scales, being unable to communicate. |
结果
主要结果指标
1. Change in postoperative pain [24 hours]
次要成果指标
1. Presence of dysphagia [24 hours]
