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

Procedural Pain Clinical Trial

— AUDIOPAW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112979
• Other study ID #: RC 36/18
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: August 24, 2019

Study information

• Verified date: October 2019
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 24, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenotonsillitis
• Pain, Procedural
• Procedural Anxiety
• Procedural Pain
• Psychomotor Agitation

Intervention

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)
• Mother's lap
45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped
• Soundproof earplugs
Disposable foam earplugs with a noise attenuation of at least 30 dB

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Frequency of use of pain killer drugs	Number of postoperative pain killers drugs administered	Within 6 hours after the awakening