NCT02207855

Brief Summary

This a study to retrospectively review our experience with the use of chloroprocaine for postoperative epidural infusions in neonates and infants. Pain scores and the need for intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of the technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

August 1, 2014

Last Update Submit

November 28, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Every 6 hours for 72 hours

Secondary Outcomes (1)

  • Pain medicine consumption

    Every 6 hours for 72 hours

Study Arms (1)

Chloroprocaine

Neonates and infants who have received chloroprocaine for epidural anesthesia.

Drug: Chloroprocaine

Interventions

ChloroprocaineDRUG
Chloroprocaine

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates and infants who have received chloroprocaine for epidural anesthesia.

You may qualify if:

  • Neonates and infants who have received chloroprocaine for epidural anesthesia.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

chloroprocaine

Study Officials

  • Joseph D Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 4, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

US(1)