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

Not Applicable

Completed

• Conditions: Adenotonsillitis; Procedural Pain; Procedural Anxiety

• Registration Number: NCT04112979
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-08-06
• Primary Completion: 2019-08-23
• Study Completion: 2019-08-24
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Study First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score (Visual Analogue Scale), self-administered (collaborative children >=8 years) or administered by parents (non-collaborative children >=8 years)	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.
Pain score (Face, Legs, Activity, Cry, Consolability scale), evaluated by parents (for children <=3 years)	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.
Pain score (Children's Hospital of Eastern Ontario Pain scale), evaluated by parents (for non-collaborative children between 3 and 7 years)	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.
Pain score (Wong-Baker Faces Pain Rating Scale), self-administered (collaborative children between 3 and 8 years)	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of use of pain killer drugs	Within 6 hours after the awakening	Number of postoperative pain killers drugs administered
Agitation	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.

Trial Locations

Locations (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-; 🇮🇹 Trieste, Italy