Pain After Strabismus Surgery

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT06689943
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Strabismus

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Tylenol — DRUG
    Tylenol for children

Study Details

At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.

Key Dates

Start date
Apr 1, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tylenol as needed
    Tylenol prescribed to be taken as needed for pain management for 48 hours after surgery
  • Experimental: Tylenol every 6hrs
    Tylenol prescribed to be taken very 6 hours for pain management for 48 hours after surgery

Primary Outcome Measure

Parent reported Pain score using the Parent's Post-operative Pain Measure [ Time Frame: From enrollment to 1 day after surgery ]

Central Contacts

  • Hanta Ralay Ranaivo Lead Clinical research coordinator, PhD
    312-227-6719
    [email protected]
  • Hawke Yoon Principal Investigator, MD
    312-227-6180

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Hanta Ralay Ranaivo Lead Clinical research coordinator, PhD
[email protected]
312-227-6719

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By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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