Trial Outcomes & Findings for Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy (NCT NCT02533999)
NCT ID: NCT02533999
Last Updated: 2018-02-22
Results Overview
To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period in children ages 3 to 18 years undergoing adenotonsillectomy with a clinical diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Assessment of subjective pain. The child will be asked by the parent to grade severity of pain daily using the Wong-Baker FACES pain rating scale in the morning before eating, drinking, or taking analgesics. The Wong-Baker FACES pain rating scale is a 0 to 10 numerical rating scale (0, 2, 4, 6, 8, 10) with faces indicating the level of pain from a happy face at a score of 0 to a crying face at a score of 10. The scale is recommended for children 3 years and older. Type and frequency of pain medication will be recorded.
COMPLETED
NA
75 participants
during the 14-day post-operative period
2018-02-22
Participant Flow
Participant milestones
| Measure |
Surgical Instrument
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Surgical Instrument
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Randomized but intervention not received
|
0
|
1
|
Baseline Characteristics
Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy
Baseline characteristics by cohort
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during the 14-day post-operative periodPopulation: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period in children ages 3 to 18 years undergoing adenotonsillectomy with a clinical diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Assessment of subjective pain. The child will be asked by the parent to grade severity of pain daily using the Wong-Baker FACES pain rating scale in the morning before eating, drinking, or taking analgesics. The Wong-Baker FACES pain rating scale is a 0 to 10 numerical rating scale (0, 2, 4, 6, 8, 10) with faces indicating the level of pain from a happy face at a score of 0 to a crying face at a score of 10. The scale is recommended for children 3 years and older. Type and frequency of pain medication will be recorded.
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery
|
7.0 Days
Interval 5.2 to 8.6
|
9.0 Days
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: intraoperatively and 24 hours post-surgery (primary period)Population: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) intraoperatively and 24 hours post-surgery (primary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Post-operative bleeding will be scored as follows: Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence. Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention. Level III. All children who require a return to the operating department for control of postoperative bleeding.
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: between 24 hours and 14 days post-operatively (secondary period)Population: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) between 24 hours and 14 days post-operatively (secondary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Post-operative bleeding will be scored as follows: Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence. Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention. Level III. All children who require a return to the operating department for control of postoperative bleeding.
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from discharge to 14 days post-operativelyPopulation: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
To assess differences in other outcomes (time to resumption of normal diet) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Return to normal diet. Normal diet is defined as consumption of the types and amount of food such that another family member would not be able to recognize that the patient had undergone throat surgery. Dietary progression from liquid to soft and solid food will be also documented. Diet will be scored as 1, liquids and soft diet only; 2, some solids; 3, mostly solids; and 4, normal diet.
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Days to Resumption of Normal Diet
|
9.0 Days
Interval 6.4 to 11.6
|
8.0 Days
Interval 5.7 to 10.3
|
SECONDARY outcome
Timeframe: from discharge to 14 days post-operativelyPopulation: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
To assess differences in other outcomes (time to resumption of normal activities) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Return to normal activity. Normal activity is defined as carrying out the same types and amounts of daily activity as before surgery, even if still associated with fatigue. Activity will be scored as 1, none; 2, very little; 3, mostly normal; 4, normal.
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Days to Resumption of Normal Activities
|
7.0 Days
Interval 6.2 to 7.8
|
8.0 Days
Interval 5.8 to 8.2
|
SECONDARY outcome
Timeframe: from discharge to 14 days post-operativelyPopulation: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
To assess differences in adverse events (emergent visits for medical care) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Adverse Events (Emergent Visits for Medical Care)
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At six-months post-operativelyPopulation: Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.
A composite score of GCBI for each patient will be calculated by assigning the individual question responses a numerical value from -2 to +2, then adding these up, dividing by the number of questions (24), and multiplying by 50 to produce a result on a scale from -100 (maximum harm) to+ 100 (maximum benefit) .
Outcome measures
| Measure |
Surgical Instrument
n=32 Participants
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 Participants
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Glasgow Children's Benefit Inventory (GCBI)
|
34.8 scores on a scale
Standard Error 4.6
|
29.1 scores on a scale
Standard Error 4.2
|
Adverse Events
Surgical Instrument
Electrosurgery
Serious adverse events
| Measure |
Surgical Instrument
n=32 participants at risk
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 participants at risk
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Tonsilar bleeding
|
0.00%
0/32 • Adverse event data were collected for a 30-day period following surgery.
The clinicaltrials.gov definitions were used. Participants were queried regarding any adverse events at each follow up phone call during the 14-day post operative period and at the 30-day post operative phone call.
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected for a 30-day period following surgery.
The clinicaltrials.gov definitions were used. Participants were queried regarding any adverse events at each follow up phone call during the 14-day post operative period and at the 30-day post operative phone call.
|
Other adverse events
| Measure |
Surgical Instrument
n=32 participants at risk
PEAK® Plasma Surgery System \[PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device\] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
PEAK® Plasma System: Surgical method for tonsillectomy and adenoidectomy.
|
Electrosurgery
n=30 participants at risk
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
Electrosurgery: Surgical method for tonsillectomy and adenoidectomy.
|
|---|---|---|
|
General disorders
Fever
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected for a 30-day period following surgery.
The clinicaltrials.gov definitions were used. Participants were queried regarding any adverse events at each follow up phone call during the 14-day post operative period and at the 30-day post operative phone call.
|
0.00%
0/30 • Adverse event data were collected for a 30-day period following surgery.
The clinicaltrials.gov definitions were used. Participants were queried regarding any adverse events at each follow up phone call during the 14-day post operative period and at the 30-day post operative phone call.
|
|
Blood and lymphatic system disorders
Dehydration
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected for a 30-day period following surgery.
The clinicaltrials.gov definitions were used. Participants were queried regarding any adverse events at each follow up phone call during the 14-day post operative period and at the 30-day post operative phone call.
|
0.00%
0/30 • Adverse event data were collected for a 30-day period following surgery.
The clinicaltrials.gov definitions were used. Participants were queried regarding any adverse events at each follow up phone call during the 14-day post operative period and at the 30-day post operative phone call.
|
Additional Information
Kathryn Blake, PharmD
Nemours Children's Specialty Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place