Clinical Trial

Pain After Strabismus Surgery

Suspended Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
The protocol needs to be changed before enrolling
Summary
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.
Protocol Amendment History 4 changes
critical Trial status changed: Not Yet Recruiting → Suspended 2026-07-31
critical Recruitment suspended: The protocol needs to be changed before enrolling 2026-07-31
notable Primary completion pushed: 2028-12-31 -> 2030-12-31 2026-07-31
minor Completion pushed: 2028-12-31 -> 2030-12-31 2026-07-31
Trial Details
NCT Number NCT06689943
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Conditions Strabismus
Enrollment 80 participants
Start Date 2026-10-01
Primary Completion 2030-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30