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

IRCCS Burlo Garofolo

Status

Completed

Conditions

Procedural Anxiety

Adenotonsillitis

Procedural Pain

Treatments

Behavioral: Music

Behavioral: Soundproof earplugs

Behavioral: Mother's lap

Study type

Interventional

Funder types

Other

Identifiers

NCT04112979

RC 36/18

Details and patient eligibility

About

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.

Enrollment

115 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

115 participants in 4 patient groups

Auditory stimulation 1 (Music)

Experimental group

Description:

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)

Treatment:

Behavioral: Music

Auditory stimulation 2 (Mother's lap)

Experimental group

Description:

45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped

Treatment:

Behavioral: Mother's lap

Soundproof earplugs

Experimental group

Description:

Disposable foam earplugs with a noise attenuation of at least 30 deciBel (dB)