Prospective Multicenter Cohort Study Evaluating Incidence and Intensity of Postoperative Pain in Pediatric Patients After Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 8
- 主要终点
- Postoperative Pain
研究概览
简要总结
The primary objective is to assess the incidence and severity of pain after major craniotomy in paediatric patients (from 1 month to 10 years of age).
The secondary objective is to determine factors associated with significant pain following paediatric neurosurgery .
详细描述
Research in the adult population has evaluated incidence and severity of post-neurosurgical pain, and effectiveness of different post-neurosurgical analgesic regimens. Several small studies report the prevalence of some period of moderate to severe pain in the first 24 postoperative hours to be from 41 to 84 % of patients. In a prospective single academic medical institution study, adult patients treated with only acetaminophen and modest amounts of opioids on an as needed basis reported moderate to severe pain for the first 2 days after surgery. These findings have supported a growing consensus that perioperative pain associated with intracranial surgery may be more significant than initially appreciated. Factors that have been associated with increased pain after intracranial surgery include sex, younger age, surgical site, and surgical approach to the site. Pain may also be a significant factor in the quality of recovery from intracranial surgery. In contrast there are few studies describing the incidence or management of pain after neurosurgery in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female children from 1 month to 10 years Of age
- •American Society of Anaesthesiologists Classification (ASA) I-III
- •Scheduled for supratentorial or infratentorial craniotomy
- •Admission to an Intensive Care Unit, Neurosurgery ward or paediatric ward of one of the hospitals included
- •Children whose parents (or legal tutors) have given their informed written consent
排除标准
- •Emergency surgery for multiple trauma.
- •Children requiring muscular relaxants during the postoperative period
- •Children whose parents (or legal tutors) denied their own consensus
结局指标
主要结局
Postoperative Pain
时间窗: 48 hs after surgery
Pain at rest and in activity will be evaluated using one or more of the following instruments: * FLACC scale for non ventilated children from 1month to 6 years of age or non ventilated children of all ages not could not be evaluated with the Numeric Rating Scale (NRS) (a ≥4 score is considered pain) * Numeric Rating Scale (NRS) for non ventilated children from 7 to 10 years of age (a ≥ 4 score is considered pain) * COMFORT scale for ventilated children from 1month to 10 years of age (a ≥ 27 score is considered distress)
次要结局
- Analgesic Drugs(48 hs after surgery)
- Complication of analgesic therapy(48 hs after surgery)
- Methods of administration of analgesic drugs(48 hs after surgery)
研究者
Pablo Mauricio Ingelmo M.D.
Paediatric Anesthesia Coordinator
San Gerardo Hospital