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NCT03672435 Clinical Trial

Strabismus Recovery With Proparacaine and Oculocardiac Reflex

Pain Clinical Trial

— OCRprop  

Official title:
Does Proparacaine Enhance Strabismus Recovery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03672435
Other study ID # ABCD OCR proparacaine
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 29, 2010
Est. completion date November 21, 2013

Study information
Verified date September 2018
Source Alaska Blind Child Discovery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date November 21, 2013
Est. primary completion date November 21, 2013
Accepts healthy volunteers No
Gender All
Age group 3 Months to 90 Years
Eligibility Inclusion Criteria: - Strabismus surgery Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Topical Solution
proparacaine 0.5% eye drop

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alaska Blind Child Discovery

References & Publications (2)

Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5. — View Citation

Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary pain (post op pain Likert scale) 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 nausea observed or described nausea (presence or absence of nausea / vomiting) hours (1-4) in recovery room
Secondary heart rate recovery room heart rate hours (1-4) while in recovery room
Secondary time to recovery time in recovery room minutes (30-240) from entry recovery room to discharge
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