Clinical trial NCT04112979: Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)
Official title: Effects of Intraoperative Auditory Stimulation on Pain and Agitation at Awakening After Pediatric Adenotonsillectomy - 4 Arms, Double-blinded, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Anxiety
Procedural Pain
Adenotonsillitis
Keywords: Auditory stimulation
adenotonsillectomy
pain
agitation
awakening
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion criteria:

* age 2 to 17 years old
* scheduled for adenotonsillectomy
* recent audiometry and tympanometry evaluation (\<1 month)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years)
timeFrame: Within 10 minutes after awakening
measure: Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)
timeFrame: Within 10 minutes after awakening
measure: Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)
timeFrame: Within 10 minutes after awakening
measure: Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years)
timeFrame: Within 10 minutes after awakening
Secondary outcomes:
measure: Agitation
timeFrame: Within 10 minutes after awakening
measure: Frequency of use of pain killer drugs
timeFrame: Within 6 hours after the awakening
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Enrico Muzzi, MD
role: STUDY_CHAIR
References:
citation: Muzzi E, Ronfani L, Bossini B, Lezcano C, Orzan E, Barbi E. Effects of Intraoperative Auditory Stimulation on Pain and Agitation on Awakening After Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Jul 1;147(7):638-645. doi: 10.1001/jamaoto.2021.0870.