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NCT Number: NCT06689943

Pain After Strabismus Surgery

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location contact

Hanta Ralay Ranaivo Lead Clinical research coordinator, PhD

CONTACT

[email protected]

312-227-6719

About this study

Main hypothesis:

Children ages 4-12 years will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (surgery to correct misaligned eyes) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery.

Primary Objective At Lurie Children's, the current standard practice is for patients to be prescribed oral acetaminophen as needed every 4-6 hours after strabismus surgery. However, making the acetaminophen "as needed" leaves room for error for parents to be underdosing their children and, thus, leads to increased pain felt by these pediatric patients. To date, there have been no studies comparing patient satisfaction outcomes between a group taking a course of scheduled acetaminophen every 6 hours and to a group instructed to take as needed. The investigators plan to study the differences between these two groups by using the Parent's Post-operative Pain Measure (PPPM) questionnaire to survey parents and the Faces Pain Scale-Revised to survey children at their post-operative appointment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between 4-12 years old
  • Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL
  • ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.

Exclusion criteria

  • ASA classification 3 or higher (patient has severe systemic disease or worse)
  • Contraindication to toradol (anesthesia)
  • Contraindication to acetaminophen
  • Previous strabismus surgery

Treatment and study plan

Tylenol

Drug

Tylenol for children

Other names: acetaminophen

Primary outcomes

  1. Parent reported Pain score using the Parent's Post-operative Pain Measure

    Time frame: From enrollment to 1 day after surgery

    Pain score reported by parent validated questionnaire- Scale from 0 to 29, 0 is no pain and 29 is the worst pain.

  2. Child reported pain score using the Faces Pain Scale- Revised

    Time frame: 2-4 days after surgery

    Child reported pain using Faces Pain Scale revised questionnaire. Scale from 0 to 5; 0 is no pain and 5 is the worst pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanta Ralay Ranaivo Lead Clinical research coordinator, PhD

CONTACT

[email protected]

312-227-6719

Hawke Yoon Principal Investigator, MD

CONTACT

312-227-6180

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Pain After Strabismus Surgery: Post-Operative Outcomes Using Courses of Acetaminophen in Children

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 15, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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