Adenotonsillitis, Procedural Anxiety, Procedural Pain
Conditions
Keywords
Auditory stimulation, adenotonsillectomy, pain, agitation, awakening
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.
Interventions
BEHAVIORALMusic
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)
BEHAVIORALMother's lap
45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped
BEHAVIORALSoundproof earplugs
Disposable foam earplugs with a noise attenuation of at least 30 dB
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Frequency of use of pain killer drugs | Within 6 hours after the awakening | Number of postoperative pain killers drugs administered |
Countries
Italy
Outcome results
None listed