Tylenol for Pain After Crossed Eyes Surgery

Overseen By Hawke Yoon Principal Investigator, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

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

Disqualifiers: Severe systemic disease, Toradol contraindication, Acetaminophen contraindication, Previous strabismus surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of scheduled doses of Tylenol in reducing pain in children after eye muscle surgery for crossed eyes, compared to Tylenol given only as needed. The researchers aim to determine if administering Tylenol every 6 hours for 48 hours reduces pain and discomfort more effectively than taking it based on parental discretion. The study targets children aged 4-12 undergoing eye muscle surgery at Lurie Children's Hospital who are otherwise healthy or have only mild health issues. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tylenol, also known as acetaminophen, is generally safe for use. Studies indicate that its side effects resemble those of a placebo, meaning most people tolerate it well. However, exceeding the recommended dose can cause problems.

When used properly, Tylenol is a common choice for managing pain, even in children. This is especially true after surgeries like strabismus surgery, which corrects crossed eyes. In past cases of this surgery, many patients took Tylenol without major issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pain after crossed eyes surgery?

Researchers are excited about the use of Tylenol for managing pain after crossed eyes surgery because it offers a non-opioid alternative for pain relief. Most treatments for post-surgical pain often involve stronger medications that can have more significant side effects or risk of dependency. Tylenol, known for its safety and mild side effect profile, provides a simpler and potentially safer option. This trial is examining two different dosing strategies: one where Tylenol is taken as needed, and another where it is taken at regular six-hour intervals, which might offer insights into optimizing pain management.

What evidence suggests that this trial's Tylenol regimens could be effective for pain after strabismus surgery?

Research has shown that Tylenol (also known as paracetamol) effectively manages post-surgical pain in children. One study found that children who had their tonsils removed experienced less pain with Tylenol. Similarly, children undergoing eye muscle surgery reported reduced pain when taking Tylenol regularly. In this trial, participants will take Tylenol either as needed or every 6 hours for pain management after crossed eyes surgery. Tylenol also reduces the need for stronger pain medications. Overall, these findings support using Tylenol to manage pain effectively after surgeries, including eye muscle surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 4-12 who have undergone strabismus surgery at Lurie Children's Hospital. The study is designed to see if a regular schedule of Tylenol reduces pain better than giving it 'as needed'. Specific eligibility criteria are not provided, but typically would include good health status and no allergies to Tylenol.

Inclusion Criteria

I am generally healthy or have a mild health condition.

My child is between 4 and 12 years old.

My child is having eye muscle surgery for crossed eyes at Lurie Children's Hospital.

Exclusion Criteria

I have had surgery for crossed eyes before.

I have a severe systemic disease.

I cannot take acetaminophen due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either regimented Tylenol every 6 hours or Tylenol as needed for 48 hours post-surgery

2 days

Post-operative appointment

Follow-up

Participants are monitored for pain and discomfort using questionnaires

2-4 days

What Are the Treatments Tested in This Trial?

Interventions

• Tylenol

Trial Overview The study tests whether taking Tylenol on a fixed schedule (every 6 hours) for two days after eye muscle surgery leads to less pain compared to when it's given based on parents' judgment of their child's pain levels ('as needed').

How Is the Trial Designed?

Group I: Tylenol every 6hrs Experimental Treatment 1 Intervention

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

Group II: Tylenol as needed Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

Multimechanistic approaches to postoperative pain relief, including the use of acetaminophen, can improve pain management, reduce the need for opioids, and lower the risk of opioid-related side effects, enhancing overall surgical outcomes.

Oral acetaminophen, especially when combined with opioids, has been shown to be safe and effective for managing postsurgical pain, and transitioning from intravenous to oral formulations is a reasonable strategy for continued pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. Pergolizzi, JV., Raffa, RB., Tallarida, R., et al.[2013]

In a study of 76 pediatric patients undergoing adenotonsillectomy, paracetamol alone was found to be effective and safe for managing postoperative pain, with an average pain intensity of 3.36 on a scale and a duration of pain lasting about 3 days.

Postoperative pain was notably more intense in patients who had surgery due to infectious conditions, but overall, the procedure had a low complication rate, with only 3.9% experiencing self-limited bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Paracetamol in the Control of Pain After Adenotonsillectomy in the Pediatric Population. Costa, R., Fernandes, Â., Fonseca, R.[2022]

A systematic review of five randomized controlled trials found that combining non-selective NSAIDs with paracetamol provides significantly better pain relief after oral surgery compared to using either drug alone.

While mild to moderate adverse events like nausea and headache were reported across treatment groups, the combination of ibuprofen and paracetamol showed fewer side effects compared to ibuprofen alone, suggesting it could be a safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combination of non-selective NSAID 400 mg and paracetamol 1000 mg is more effective than each drug alone for treatment of acute pain. A systematic review. Alexander, L., Hall, E., Eriksson, L., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06689943

NCT06689943 | Pain After Strabismus Surgery 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 ...

2. withpower.com withpower.com/trial/phase-2-strabismus-2025-20b18

Tylenol for Pain After Crossed Eyes Surgery In a study of 76 pediatric patients undergoing adenotonsillectomy, paracetamol alone was found to be effective and safe for managing postoperative pain, with an ...

3. clinicaltrial.be clinicaltrial.be/en/details/459026?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Pain After Strabismus Surgery Children ages 4-12 years will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7611577/

[Strabismus Surgery in Children. The Effect of Paracetamol ... Intraoperative administration of rectal paracetamol or topical 0.5% bupivacaine was most effective in the treatment of postoperative pain for strabismus surgery ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S240560302100042X

Effect of Paracetamol on postoperative pain in children ... The present study illustrated that paracetamol reduces postoperative nausea and vomiting. Also, it diminished postoperative pain and the need for opioids.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8389911/

An Opioid-free Anesthesia Protocol for Pediatric ... From April 1, 2017, to January 1, 2019, 18% of strabismus cases still received intraoperative acetaminophen, whereas 90% of strabismus cases ...

7. childrenscolorado.org childrenscolorado.org/doctors-and-departments/departments/eye/tests-services-procedures/strabismus-surgery/

Strabismus Surgery Quality, Patient Safety and Outcomes ... Some patients find the idea of eye surgery frightening, but fortunately, strabismus surgery is exceptionally safe.