Trial Outcomes & Findings for Pediatric Tonsillectomy Pain Reduction Study (NCT NCT00678379)

NCT ID: NCT00678379

Last Updated: 2017-07-02

Results Overview

The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: Post-operative thru day 7
• Results posted on: 2017-07-02

Participant Flow

Participant milestones

Measure	Normal Saline Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine (1%) + Bupivacaine 0.5% Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Overall Study STARTED	40	40	40
Overall Study COMPLETED	34	37	36
Overall Study NOT COMPLETED	6	3	4

Reasons for withdrawal

Measure	Normal Saline Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine (1%) + Bupivacaine 0.5% Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Overall Study Injection performed after tonsillectomy	2	0	1
Overall Study Incomplete Data	4	3	3

Baseline Characteristics

Pediatric Tonsillectomy Pain Reduction Study

Baseline characteristics by cohort

Measure	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)	Total n=120 Participants Total of all reporting groups
Age, Continuous	6 years n=5 Participants	7 years n=7 Participants	8 years n=5 Participants	7 years n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	53 Participants n=4 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	40 participants n=5 Participants	120 participants n=4 Participants

PRIMARY outcome

Timeframe: Post-operative thru day 7

Population: Number of patients randomized to each group

The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Total Number of Post-operative Doses of Analgesics.	12 number of doses Interval 10.0 to 16.5	12 number of doses Interval 9.0 to 15.0	14 number of doses Interval 9.0 to 16.8

SECONDARY outcome

Timeframe: in recovery room

Population: per group doses

The median number of intravenous fentanyl doses administered in the PACU due to pain

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Median Number of Pain Medication Doses	3 number of doses Interval 2.0 to 4.0	3.0 number of doses Interval 3.0 to 5.0	3 number of doses Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Day of Surgery

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Total Time Until Discharge From Hospital.	111 minutes Interval 81.0 to 142.0	122 minutes Interval 90.0 to 188.0	120 minutes Interval 79.0 to 175.0

SECONDARY outcome

Timeframe: in recovery room; post-operative days 1,3,5 & 7

Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Mean Visual Analog Scale Pain Number. In recovery room	3 pain score Interval 2.0 to 4.0	3 pain score Interval 2.0 to 4.0	3 pain score Interval 2.0 to 4.0
Mean Visual Analog Scale Pain Number. day 1	4 pain score Interval 3.0 to 5.0	3 pain score Interval 2.0 to 6.0	5 pain score Interval 4.0 to 5.2
Mean Visual Analog Scale Pain Number. day 3	2.5 pain score Interval 2.0 to 4.0	3 pain score Interval 1.0 to 3.5	3 pain score Interval 2.0 to 5.0
Mean Visual Analog Scale Pain Number. day 5	2 pain score Interval 1.0 to 5.0	3 pain score Interval 1.5 to 5.0	3 pain score Interval 2.0 to 6.0
Mean Visual Analog Scale Pain Number. day 7	2 pain score Interval 1.0 to 5.0	2.5 pain score Interval 1.0 to 3.2	2 pain score Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: post-operative days 1,3,5 & 7.

Population: per group data

The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Number and Percent of Participants Able to Tolerate Only Liquids post-op day 1	33 Participants	16 Participants	30 Participants
Number and Percent of Participants Able to Tolerate Only Liquids post-op day 3	13 Participants	8 Participants	23 Participants
Number and Percent of Participants Able to Tolerate Only Liquids post op day 5	10 Participants	13 Participants	19 Participants
Number and Percent of Participants Able to Tolerate Only Liquids post op day 7	11 Participants	6 Participants	10 Participants

SECONDARY outcome

Timeframe: post-operative days 1,3,5 & 7.

Population: per group diet

The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Number and Percent of Participants Able to Tolerate Only a Soft Diet post-op day 1	22 Participants	26 Participants	26 Participants
Number and Percent of Participants Able to Tolerate Only a Soft Diet post-op day 3	26 Participants	18 Participants	18 Participants
Number and Percent of Participants Able to Tolerate Only a Soft Diet post op day 5	17 Participants	13 Participants	18 Participants
Number and Percent of Participants Able to Tolerate Only a Soft Diet post op day 7	10 Participants	13 Participants	14 Participants

SECONDARY outcome

Timeframe: post-operative days 1,3,5 & 7.

The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7

Outcome measures

Measure	Lidocaine (1%) + Bupivacaine 0.5% n=40 Participants Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Normal Saline n=40 Participants Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 Participants Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Number and Percent of Participants Able to Tolerate a Regular Diet post-op day 1	4 Participants	7 Participants	1 Participants
Number and Percent of Participants Able to Tolerate a Regular Diet post-op day 3	8 Participants	18 Participants	12 Participants
Number and Percent of Participants Able to Tolerate a Regular Diet post op day 5	18 Participants	21 Participants	14 Participants
Number and Percent of Participants Able to Tolerate a Regular Diet post op day 7	26 Participants	24 Participants	22 Participants

Adverse Events

Normal Saline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Lidocaine (1%) + Bupivacaine 0.5%

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Normal Saline n=40 participants at risk Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline	Lidocaine (1%) + Bupivacaine 0.5% n=40 participants at risk Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%)	Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg n=40 participants at risk Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
General disorders Dehydration	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	7.5% 3/40 • Number of events 3 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	7.5% 3/40 • Number of events 3 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.
General disorders Emergency Department admission	0.00% 0/40 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.
Blood and lymphatic system disorders Bleeding	7.5% 3/40 • Number of events 3 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.
Nervous system disorders Lingual nerve palsy	0.00% 0/40 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	0.00% 0/40 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.
General disorders Severe pain	0.00% 0/40 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	2.5% 1/40 • Number of events 1 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.	0.00% 0/40 • Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery. We used the same definition.

Additional Information

Jonathan Moss MD

Charlotte Eye Ear Nose and Throat

Phone: 704-295-3000

Email: jmoss@ceenta.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place