N/A N=75 Randomized Single-blind Treatment

Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy

Sleep Disordered Breathing

Bottom Line

View on ClinicalTrials.gov: NCT02533999 ↗

Enrolled (actual)

Serious AEs

1.6%

Results posted

Feb 2018

Primary outcome: Primary: Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery — 7.0; 9.0 Days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PEAK® Plasma System (Device); Electrosurgery (Device)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: Nemours Children's Clinic
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery	7.0; 9.0	—
SECONDARY Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period)	0; 0	—
SECONDARY Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period)	0; 1	—
SECONDARY Days to Resumption of Normal Diet	9.0; 8.0	—
SECONDARY Days to Resumption of Normal Activities	7.0; 8.0	—
SECONDARY Adverse Events (Emergent Visits for Medical Care)	2; 1	—

Summary

Given the large numbers of children who undergo tonsillectomy (by the time a child is 15 years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity, and direct and indirect costs associated with absences for child from school or parent from work or other responsibilities, it is vitally important to identify surgical techniques which will minimize pain and serious negative outcomes. This study aims to compare a new surgical technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis of sleep-disordered breathing. In this project, the investigator will evaluate intra-operative outcomes including, surgery time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14 days following surgery. The hypothesis is that there is no difference in outcomes between the traditional extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced Peak® Surgery System. The long-term goal is to minimize pain and risk of bleeding and shorten the time to resumption of normal eating and activities in children undergoing tonsillectomy.

Eligibility Criteria

Inclusion Criteria

Patients are aged 3 up to 18 years old; children younger than 3 years are excluded because of a higher risk of perioperative complications such as requiring an overnight hospitalization and dehydration after discharge resulting in an emergency department visit or hospitalization
Clinical diagnosis of sleep disordered breathing or obstructive sleep apnea 10 or recurrent tonsillitis
Presence of adenotonsillar hypertrophy

Exclusion Criteria

Diagnosis of bleeding disorders*
Craniofacial malformation
Previous adenotonsillectomy
Suspected lymphoma
Developmental delay
Diabetes or any other disease that slows wound healing
Peritonsillar abscess
Expressive language disorder
Hematologic wound healing disorder or necrotizing dermatosis,
Implanted electric device
Mucopolysaccharidosis
Use of nonsteroidal anti-inflammatory drugs in the two weeks prior to the surgery
Allergy to medication(s) used in this protocol
Other planned surgical procedure during this surgical period
Chronic pain disorder
Planned hospital admission
We will use the following set of questions to evaluate for bleeding issues. If all are answered "no", then the child will be enrolled. If any are answered "yes", the child will be excluded and the family will be referred for a Hematology consult.
Has your child been told he/she has a bleeding disorder?
Does anyone in the child's family (grandmother, grandfather, mother, father, siblings) have a known bleeding disorder?
Does your child have easy bruising or difficulty stopping bleeding when he/she gets a cut or scratch?
If your child has had had surgery before, did the surgeon indicate that controlling bleeding was difficult or was your child required to come back to the hospital for bleeding control?

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02533999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.