Strabismus Recovery With Proparacaine and Oculocardiac Reflex

NCT03672435 | Completed FDA Drug

• 1 other identifier: ABCD OCR proparacaine
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Strabismus; Bradycardia; Nausea; Pain

Keywords

post operative recovery; oculocardiac reflex; extra ocular muscle; conjunctiva; numbing drop; heart rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• nausea

  hours (1-4) in recovery room

• heart rate

  hours (1-4) while in recovery room

• time to recovery

  minutes (30-240) from entry recovery room to discharge

Study Arms (2)

proparacaine

Received topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery

Drug: Topical Solution

No proparacaine

Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery

Interventions

Topical Solution DRUG

proparacaine 0.5% eye drop

Also known as: proparacaine

proparacaine

Eligibility Criteria

• Age: 3 Months - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

strabismus surgery patients

You may qualify if:

• Strabismus surgery

You may not qualify if:

• none

Sponsors & Collaborators

• Alaska Blind Child Discovery: lead

Related Publications (2)

• 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.

  PMID: 31819352 BACKGROUND

• 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.

  PMID: 29733898 RESULT

MeSH Terms

Conditions

Strabismus; Bradycardia; Nausea; Pain

Interventions

Solutions; proxymetacaine

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Robert W Arnold, MD

  Alaska Blind Child Discovery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 14, 2018
• Study Start: July 29, 2010
• Primary Completion: November 21, 2013
• Study Completion: November 21, 2013
• Last Updated: October 19, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: current- ongoing
• Access Criteria: public