Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- additional administration of analgesics
研究概览
简要总结
There are difficulties in the progress of the study and cancel the plan. The purpose of this study is to evaluate the postoperative pain control using non - opioidal analgesics in children. The investigators will investigate the effect of single use and combination of caldorol(ibuprofen) compare to denogan(propacetamol) in children.
Participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years old are divided 3 groups(caldolor, denogan, combination). Each groups are received a medication by protocol during surgery. After operation patient's pain score and use of additional analgesics are recorded in postanesthesia care unit and general ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo laparoscopic inguinal hernia surgery
- •American Society of Anesthesiologists physical status classification 1 or 2
- •Children aged 6 months to 6 years
排除标准
- •history of Gastrointestinal bleeding
- •history or laboratory finding of suspected renal or hepatic dysfunction
- •bronchial asthma
- •bleeding disorder
- •hypersensitivity to NSAID or propacetamol
- •disagreement of investigation
- •The researcher determines that participation is inappropriate due to other reasons.
研究组 & 干预措施
caldolor
intravenous caldolor injection during intraoperative period
干预措施: ibuprofen (caldolor 10 mg / kg) (Drug)
denogan
intravenous denogan injection during intraoperative period
干预措施: propacetamol (denogan 30 mg / kg) (Drug)
combination
intravenous denogan and caldolor injection during intraoperative period
干预措施: ibuprofen + propacetamol (Drug)
结局指标
主要结局
additional administration of analgesics
时间窗: during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour
whether additional analgesics are administered during the postanesthesia care unit due to pain
次要结局
- pain score (FLACC)(Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour))
- pain score (CHEOPS)(Participant's pain score is evaluated by FLACC at the time of leaving the postanesthesia care unit(PACU) (up to 1 hour))
- pain score (PPPM scale)(The PPPM scale is measured at 24 hours after surgery)
- incidence of complications(during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour)