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Completed

NCT Number: NCT04112979

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

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.

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Key information

Conditions

Procedural Anxiety Aberrant Motor Behavior in Dementia Adenotonsillitis Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Pain Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Mother's lap

Behavioral

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

Soundproof earplugs

Behavioral

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

Primary outcomes

  1. Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years)

    Time frame: Within 10 minutes after awakening

    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.

  2. Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)

    Time frame: Within 10 minutes after awakening

    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.

  3. Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)

    Time frame: Within 10 minutes after awakening

    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.

  4. Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years)

    Time frame: Within 10 minutes after awakening

    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.

Secondary outcomes

  1. Agitation

    Time frame: Within 10 minutes after awakening

    Evaluated using the Paediatric Anesthesia Emergence Delirium (PAED) scale, ranging form 0 to 20. Higher scores correspond to higher levels of agitation.

  2. Frequency of use of pain killer drugs

    Time frame: Within 6 hours after the awakening

    Number of postoperative pain killers drugs administered

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Acronym: AUDIOPAW

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2019
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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