Strabismus Recovery With Proparacaine and Oculocardiac Reflex (OCRprop)

October 14, 2020 updated by: Alaska Blind Child Discovery

Does Proparacaine Enhance Strabismus Recovery

Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.

Study Type

Observational

Enrollment (Actual)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

strabismus surgery patients

Description

Inclusion Criteria:

  • Strabismus surgery

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
proparacaine
Received topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery
Drug: Topical Solution
proparacaine 0.5% eye drop
Other Names:
  • proparacaine
No proparacaine
Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain (post op pain Likert scale)
Time Frame: hours (1-4) in recovery room
pain scale description / observation.. Pain is ranked by patient or nurse from 0 (no pain) to 9 (much pain)
hours (1-4) in recovery room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nausea
Time Frame: hours (1-4) in recovery room
observed or described nausea (presence or absence of nausea / vomiting)
hours (1-4) in recovery room
heart rate
Time Frame: hours (1-4) while in recovery room
recovery room heart rate
hours (1-4) while in recovery room
time to recovery
Time Frame: minutes (30-240) from entry recovery room to discharge
time in recovery room
minutes (30-240) from entry recovery room to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaska Blind Child Discovery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 29, 2010

Primary Completion (ACTUAL)

November 21, 2013

Study Completion (ACTUAL)

November 21, 2013

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCD OCR proparacaine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Website access

IPD Sharing Time Frame

current- ongoing

IPD Sharing Access Criteria

public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: deidentified OCR topical anesthetic recovery outcomes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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