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

NCT04112979 | Completed

• 1 other identifier: RC 36/18
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Anxiety; Procedural Pain; Adenotonsillitis

Keywords

Auditory stimulation; adenotonsillectomy; pain; agitation; awakening

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Agitation

  Within 10 minutes after awakening

• Frequency of use of pain killer drugs

  Within 6 hours after the awakening

Study Arms (4)

Auditory stimulation 1 (Music)

EXPERIMENTAL

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

Auditory stimulation 2 (Mother's lap)

EXPERIMENTAL

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

Behavioral: Mother's lap

Soundproof earplugs

EXPERIMENTAL

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

Behavioral: Soundproof earplugs

No stimulation

NO INTERVENTION

Current standard of care

Interventions

Music BEHAVIORAL

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)

Auditory stimulation 1 (Music)

Mother's lap BEHAVIORAL

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

Auditory stimulation 2 (Mother's lap)

Soundproof earplugs BEHAVIORAL

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

Soundproof earplugs

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Location

Related Publications (1)

• 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.

  PMID: 34014258 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Pain; Psychomotor Agitation

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Enrico Muzzi, MD

  IRCCS Burlo Garofolo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: October 2, 2019
• Study Start: March 1, 2018
• Primary Completion: August 23, 2019
• Study Completion: August 24, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

IT (1)