Effects of Intraoperative Auditory Stimulation on Pain and Agitation at Awakening After Pediatric Adenotonsillectomy - 4 Arms, Double-blinded, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)
研究概览
简要总结
Adenotonsillectomy (AT) is one of the most common pediatric surgical procedures. The management of postoperative pain and agitation after AT is still a controversial issue. Safety considerations limit the use of opioids and non-steroidal anti-inflammatory drugs, leading to inadequate control of the high levels of postoperative pain experienced by AT patients. Along with pain killers, non-pharmacological strategies have remarkable impact on pain management in children. A systematic review and meta-analysis published in The Lancet in 2015 on adult patients suggest that auditory stimulation with music in the perioperative setting, and even when patients are under general anaesthesia, can reduce postoperative pain, anxiety, and analgesia needs. The authors concluded that there is sufficient evidence to implement auditory stimulation in the treatment of all adult surgical patients, regardless of the mode of administration. Up to now, no research has investigated the effects of intraoperative auditory stimulation on pain and agitation upon awakening after AT in the pediatric population. Objective of this study is to determine the effects of intraoperative auditory stimulation on pain and agitation upon awakening after pediatric AT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2 to 17 years old
- •scheduled for adenotonsillectomy
- •recent audiometry and tympanometry evaluation (<1 month)
排除标准
- •no informed consent
- •other combined surgical procedures
- •comorbidities (e.g. congenital anomalies of the head-and-neck, psychomotor delay, autism spectrum disorders)
- •American Society of Anesthesiologists (ASA) Classification score >2
- •ongoing chronic pharmacological therapy
- •first language not Italian
- •environmental noise exceeding limits in the operating room
研究组 & 干预措施
No stimulation
Current standard of care
Auditory stimulation 1 (Music)
45 deciBel Sensation Level (dB SL), normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013)
干预措施: Music (Behavioral)
Auditory stimulation 2 (Mother's lap)
45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped
干预措施: Mother's lap (Behavioral)
Soundproof earplugs
Disposable foam earplugs with a noise attenuation of at least 30 deciBel (dB)
干预措施: Soundproof earplugs (Behavioral)
结局指标
主要结局
Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)
时间窗: Within 10 minutes after awakening
Pain score for \>=8 years old children will be evaluated with Visual Analogue Scale (self administered if collaborative; administered by parents if non-collaborative children), ranged 0-10. Higher scores correspond to higher levels of pain. In accordance with previous studies (Ferreira-Valente et al. Validity of four pain intensity rating scales. Pain 2011;152:2399-2404), the scores of Wong-Baker Faces Pain Rating scale and Visual Analogue Scale will be considered comparable and combined in one outcome variable.
Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)
时间窗: Within 10 minutes after awakening
For children \<=3 years, pain score will be evaluated by parents using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years)
时间窗: Within 10 minutes after awakening
For non-collaborative children between 3 and 7 years, pain score will be evaluated by parents using the Children's Hospital of Eastern Ontario Pain (CHEOPS) scale, ranged 0-10. Higher scores correspond to higher levels of pain. In accordance with previous studies, the scores of the Face, Legs, Activity, Cry, Consolability (FLACC) scale and of the Children's Hospital of Eastern Ontario Pain (CHEOPS) scale will be considered comparable and combined in one outcome variable.
Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years)
时间窗: Within 10 minutes after awakening
Pain score for collaborative children between 3 and 8 years will be evaluated with the self-administered Wong-Baker Faces Pain Rating scale, ranged 0-10. Higher scores correspond to higher levels of pain.
次要结局
- Frequency of use of pain killer drugs(Within 6 hours after the awakening)
- Agitation(Within 10 minutes after awakening)