Status:
COMPLETED
Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)
Lead Sponsor:
IRCCS Burlo Garofolo
Conditions:
Procedural Anxiety
Procedural Pain
Eligibility:
All Genders
2-17 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2019
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04112979
Start Date
March 1 2018
End Date
August 24 2019
Last Update
October 2 2019
Active Locations (1)
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1
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Italy, 34137