Trial Outcomes & Findings for Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine (NCT NCT00616577)
NCT ID: NCT00616577
Last Updated: 2019-04-25
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Over 24 hours
Results posted on
2019-04-25
Participant Flow
IRB annual renewal indicates 26 participants Resident on the project indicates only 22 started the study.
Participant milestones
| Measure |
Group CB
Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
|
Group CA
Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.
Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
|
Group LIA
Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
7
|
|
Overall Study
COMPLETED
|
6
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Over 24 hoursPopulation: PI left institution and records cannot be located.
Outcome measures
Outcome data not reported
Adverse Events
Group CB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group CA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group LIA
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place