NCT04112979

Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)

Effects of Intraoperative Auditory Stimulation on Pain and Agitation at Awakening After Pediatric Adenotonsillectomy - 4 Arms, Double-blinded, Randomized, Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Procedural Anxiety
• Procedural Pain
• Adenotonsillitis

Interventions

Type	Name	Description
BEHAVIORAL	Music	45 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)
BEHAVIORAL	Mother's lap	45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped
BEHAVIORAL	Soundproof earplugs	Disposable foam earplugs with a noise attenuation of at least 30 dB

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-08-23
• Completion: 2019-08-24
• First posted: 2019-10-02
• Last updated: 2019-10-02

Locations

1 site across 1 country: Italy