Pain After Strabismus Surgery

February 15, 2025 updated by: Hawke H. Yoon, Ann & Robert H Lurie Children's Hospital of Chicago

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hawke Yoon Principal Investigator, MD
  • Phone Number: 312-227-6180

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tylenol as needed
Tylenol prescribed to be taken as needed for pain management for 48 hours after surgery
Drug: Tylenol
Tylenol for children
Other Names:
  • acetaminophen
Experimental: Tylenol every 6hrs
Tylenol prescribed to be taken very 6 hours for pain management for 48 hours after surgery
Drug: Tylenol
Tylenol for children
Other Names:
  • acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 1 day after surgery
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.
2-4 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-7067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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