Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
研究概览
简要总结
The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 year to < 8 years
- •Undergoing strabismus surgery under general anesthesia
- •No previous surgery on muscle to be operated
- •No known allergy to lidocaine or bupivacaine
- •Investigator willing to inject subtenons NS or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or Hypromellose 0.3% gel (GenTeal Severe Dry Eye Relief) to all surgical wounds at the end of strabismus surgery.
排除标准
- 未提供
研究组 & 干预措施
subtenons anesthetic and topical control
Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
干预措施: subtenons anesthetic - preservative-free bupivacaine 0.75% (Drug)
subtenons anesthetic and topical control
Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery
干预措施: topical control - 0.5 cc of Hypromellose 0.3% gel (Drug)
topical anesthetic and subtenons control
Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
干预措施: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel (Drug)
topical anesthetic and subtenons control
Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery
干预措施: subtenons control - 0.5 cc of Normal Saline (Drug)
topical control and subtenons control
Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
干预措施: topical control - 0.5 cc of Hypromellose 0.3% gel (Drug)
topical control and subtenons control
Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery
干预措施: subtenons control - 0.5 cc of Normal Saline (Drug)
结局指标
主要结局
Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
时间窗: 0-30 minutes post-operative
Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for "Average pain score over the first 30 post-operative minutes using the CHEOPS scale." for each group.
次要结局
- Number of Participants Who Required Anti-emetic Medication Post-operatively(Total time in post-operative recovery - up to 6 hours)
- Total Narcotic Use During Post-operative Recovery(Total time in post-operative recovery - up to 6 hours)
- Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)(1 week (+/- 3 days) post operatively)
- Peak Pain Score During First 30 Minutes(0-30 minutes post-operative)
- Peak Pain Score(0-150 minutes post-operative)
- Average Time to Discharge(0-150 minutes post-operative)
- Number of Participants With Post Operative Nausea and Vomiting(0-150 minutes post-operative)