Trial Outcomes & Findings for Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery (NCT NCT01638052)

Results Overview

Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

60 minutes

Results posted on

2021-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	0.25% Bupivacaine This is our standard of care concentration	0.25% Bupivacaine + Clonidine These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. 0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	28	28
Overall Study COMPLETED	28	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.25% Bupivacaine n=28 Participants This is our standard of care concentration	0.25% Bupivacaine + Clonidine n=28 Participants These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. 0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine	Total n=56 Participants Total of all reporting groups
Age, Continuous	6.9 years n=28 Participants	7.5 years n=28 Participants	7.2 years n=56 Participants
Sex: Female, Male Female	14 Participants n=28 Participants	14 Participants n=28 Participants	28 Participants n=56 Participants
Sex: Female, Male Male	14 Participants n=28 Participants	14 Participants n=28 Participants	28 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	28 Participants n=28 Participants	28 Participants n=28 Participants	56 Participants n=56 Participants

PRIMARY outcome

Timeframe: 60 minutes

Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).

Outcome measures

Outcome measures
Measure	0.25% Bupivacaine n=28 Participants This is our standard of care concentration	0.25% Bupivacaine + Clonidine n=28 Participants These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. 0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Average Observer-Rated Patient Pain Scores	2 units on a scale Standard Deviation 1.05	1.9 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: 24 hours

Incidence of nausea/vomiting during 24 hour observation

Outcome measures

Outcome measures
Measure	0.25% Bupivacaine n=28 Participants This is our standard of care concentration	0.25% Bupivacaine + Clonidine n=28 Participants These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. 0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Number of Participants With Nausea/Vomiting	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 24 hours

Count of participants who will require use of rescue analgesic medication in the initial 24 hours postoperatively as recorded in the hospital or by parents at home following discharge.

Outcome measures

Outcome measures
Measure	0.25% Bupivacaine n=28 Participants This is our standard of care concentration	0.25% Bupivacaine + Clonidine n=28 Participants These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. 0.25% Bupivacaine + Clonidine : Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively	18 Participants	22 Participants

Adverse Events

0.25% Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.25% Bupivacaine + Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Santhanam Suresh, MD

Ann & Robert H. Lurie Children's Hospital of Chicago

Phone: 312-227-5147

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place