Pain After Strabismus Surgery

NCT06689943 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024-7067
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Strabismus

Keywords

pain; strabismus surgery

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Study Arms (2)

Tylenol as needed

ACTIVE COMPARATOR

Tylenol prescribed to be taken as needed for pain management for 48 hours after surgery

Drug: Tylenol

Tylenol every 6hrs

EXPERIMENTAL

Tylenol prescribed to be taken very 6 hours for pain management for 48 hours after surgery

Drug: Tylenol

Interventions

Tylenol DRUG

Tylenol for children

Also known as: acetaminophen

Tylenol as needed; Tylenol every 6hrs

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Walther-Larsen S, Aagaard GB, Friis SM, Petersen T, Moller-Sonnergaard J, Romsing J. Structured intervention for management of pain following day surgery in children. Paediatr Anaesth. 2016 Feb;26(2):151-7. doi: 10.1111/pan.12811. Epub 2015 Nov 12.

  PMID: 26559643 BACKGROUND

• Vons KM, Bijker JB, Verwijs EW, Majoor MH, de Graaff JC. Postoperative pain during the first week after adenoidectomy and guillotine adenotonsillectomy in children. Paediatr Anaesth. 2014 May;24(5):476-82. doi: 10.1111/pan.12383. Epub 2014 Mar 20.

  PMID: 24646093 BACKGROUND

• Ghai B, Makkar JK, Wig J. Postoperative pain assessment in preverbal children and children with cognitive impairment. Paediatr Anaesth. 2008 Jun;18(6):462-77. doi: 10.1111/j.1460-9592.2008.02433.x. Epub 2008 Mar 18.

  PMID: 18363630 BACKGROUND

• de Azevedo CB, Carenzi LR, de Queiroz DL, Anselmo-Lima WT, Valera FC, Tamashiro E. Clinical utility of PPPM and FPS-R to quantify post-tonsillectomy pain in children. Int J Pediatr Otorhinolaryngol. 2014 Feb;78(2):296-9. doi: 10.1016/j.ijporl.2013.11.027. Epub 2013 Dec 1.

  PMID: 24370467 BACKGROUND

• Chambers CT, Reid GJ, McGrath PJ, Finley GA. Development and preliminary validation of a postoperative pain measure for parents. Pain. 1996 Dec;68(2-3):307-13. doi: 10.1016/s0304-3959(96)03209-5.

  PMID: 9121819 BACKGROUND

• Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.

  PMID: 14527704 BACKGROUND

MeSH Terms

Conditions

Strabismus; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Hanta Ralay Ranaivo Lead Clinical research coordinator, PhD

CONTACT

312-227-6719; eyeresearch@luriechildrens.org

Hawke Yoon Principal Investigator, MD

CONTACT

312-227-6180

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Ophthalmologist

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

US (1)