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

Study Overview
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Brief Summary
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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.

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

Conditions
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Procedural Anxiety, Procedural Pain, Adenotonsillitis

Intervention / Treatment
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* Behavioral: Music
* Behavioral: Mother's lap
* Behavioral: Soundproof earplugs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auditory stimulation 1 (Music)<br>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) | Behavioral: Music<br>* 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)<br>|
| Experimental: Auditory stimulation 2 (Mother's lap)<br>45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped | Behavioral: Mother's lap<br>* 45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped<br>|
| Experimental: Soundproof earplugs<br>Disposable foam earplugs with a noise attenuation of at least 30 deciBel (dB) | Behavioral: Soundproof earplugs<br>* Disposable foam earplugs with a noise attenuation of at least 30 dB<br>|
| No Intervention: No stimulation<br>Current standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years) | 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. | Within 10 minutes after awakening | 
| Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years) | 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. | Within 10 minutes after awakening | 
| Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years) | 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. | Within 10 minutes after awakening | 
| Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years) | 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. | Within 10 minutes after awakening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agitation | Evaluated using the Paediatric Anesthesia Emergence Delirium (PAED) scale, ranging form 0 to 20. Higher scores correspond to higher levels of agitation. | Within 10 minutes after awakening | 
| Frequency of use of pain killer drugs | Number of postoperative pain killers drugs administered | Within 6 hours after the awakening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auditory stimulation, adenotonsillectomy, pain, agitation, awakening