Trial Outcomes & Findings for Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery (NCT NCT02436265)

Results Overview

Will track the trend of pain scores for both arms to note differences in pain score based on intervention received. Pain scores will be based on a patient verbal response of 0-10 pain, 0 being no pain and 10 being worst pain, or with a FLACC score (Face, Legs, Activity, Cry, Consolability scale) of 0-10 if patient unable to communicate verbally

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

24 hours

Results posted on

2021-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Ropivacaine Group 1 Ropivacaine Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine Ropivacaine: Ropivacaine only	Group 2 Ropivacaine and Dexamethasone Group 2 Ropivacaine/dexamethasone Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine and 0.1mg/kg of intravenous dexamethasone immediately after caudal placement Dexamethasone: IV dexamethasone Ropivacaine: Ropivacaine only
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

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	Ropivacaine Only Group n=3 Participants Patients receiving caudals with local anesthetic, but no IV dexamethasone	Ropivaciane + IV Dexamethasone n=4 Participants Patients receiving caudals with local anesthetic +0/1mg/kg IV dexamethasone	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=3 Participants	4 Participants n=4 Participants	7 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	1 Participants n=4 Participants	2 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	3 Participants n=4 Participants	5 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24 hours

Population: The study was abandoned/terminated. Enrollment in the trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. No participants were analyzed.

Will track the trend of pain scores for both arms to note differences in pain score based on intervention received. Pain scores will be based on a patient verbal response of 0-10 pain, 0 being no pain and 10 being worst pain, or with a FLACC score (Face, Legs, Activity, Cry, Consolability scale) of 0-10 if patient unable to communicate verbally

Outcome measures

Outcome data not reported

Adverse Events

Ropivacaine Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine + IV Dexamethasone

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

Aali shah MD

Indiana University

Phone: 317-944-9981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place