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

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Tylenol for pain after crossed eyes surgery?

Research shows that acetaminophen (Tylenol) can help manage pain after various surgeries, including pediatric ophthalmic surgeries and adenotonsillectomy, suggesting it may also be effective for pain after crossed eyes surgery. ^{1 2 3 4 5}

Is Tylenol (acetaminophen) generally safe for use in humans?

Tylenol (acetaminophen) is generally safe for use in humans, with adverse events similar to those of a placebo in most cases, except at higher doses or when combined with opioids. Common mild side effects include nausea, vomiting, headache, and dizziness. ^{4 6 7 8 9}

How does Tylenol differ from other drugs for pain after crossed eyes surgery?

Tylenol (acetaminophen) is unique because it is often used alone or with nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control, avoiding the need for stronger opioids, which are sometimes prescribed for more severe pain. This makes it a simpler and potentially safer option for managing postoperative pain in many cases. ^{1 2 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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').

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pain Control Following Photorefractive Keratectomy: A Prospective Clinical Trial Comparing Codeine Versus Oxycodone for the Management of Postoperative Pain. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Codeine Plus Acetaminophen for Pain After Photorefractive Keratectomy: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial. [2020]

3. India pubmed.ncbi.nlm.nih.gov

Postoperative analgesic efficacy of single high dose and low dose rectal acetaminophen in pediatric ophthalmic surgery. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Paracetamol in the Control of Pain After Adenotonsillectomy in the Pediatric Population. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Ketoprofen for add-on pain treatment to paracetamol after strabismus surgery in children. [2018]

6. Sweden 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Single dose oral analgesics for postoperative pain have few adverse events. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Analgesia in Postoperative Adult Strabismus Patients. [2023]

11. Denmark pubmed.ncbi.nlm.nih.gov

Analgesics requirement after anterior segment surgery. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Tenoxicam, Paracetamol, and Their Combination in Postoperative Pain After Double-Jaw Surgery. [2023]