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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04112979
Other study ID # RC 36/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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