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

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

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.

Study Overview

• Status: Completed
• Conditions: Procedural Pain; Procedural Anxiety; Adenotonsillitis
• Intervention / Treatment: Behavioral: Music; Behavioral: Mother's lap; Behavioral: Soundproof earplugs

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Enrico Muzzi, MD, IRCCS Burlo Garofolo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 24, 2019

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pain; agitation; Auditory stimulation; adenotonsillectomy; awakening
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Pain, Procedural
• Other Study ID Numbers: RC 36/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No