Acetaminophen + Ibuprofen for Post-Surgery Pain in Children

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor Research Institute

Disqualifiers: Allergy to acetaminophen, ibuprofen, pregnancy, others

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: 1

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores pain management in children after surgery using two common pain relievers: acetaminophen (Tylenol) and ibuprofen (Advil). One group will alternate these medications every three hours, while another group will take them together every six hours. The aim is to determine which method better controls pain. Children aged 3 to 18 who have undergone surgeries like hernia repair or appendectomy and are not allergic to these medications may qualify. The trial takes place at McLane Children's Hospital Temple Market. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how these medications can benefit more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for acetaminophen and ibuprofen?

Research shows that acetaminophen and ibuprofen are generally safe for children when used to manage pain. Studies indicate that these two medicines have similar side effects and are usually well-tolerated. They also tend to cause fewer problems compared to stronger painkillers like opioids.

After surgery, acetaminophen helps with mild pain and fever, while ibuprofen reduces swelling. Both medicines can be used together to manage pain effectively. This method is common and has been shown to provide pain relief similar to that of opioids, which are much stronger drugs.

Overall, these medicines are considered safe for children, especially when the dose is adjusted based on the child's weight. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combined use of acetaminophen and ibuprofen for post-surgery pain in children because it offers a potentially more efficient way to manage pain. Unlike standard treatments that often rely on either medication alone, this approach combines them to enhance pain relief. The alternating treatment every three hours might provide more consistent pain management, reducing the need for stronger painkillers like opioids, which come with more side effects. The weight-based dosing is also tailored to each child's needs, potentially improving safety and effectiveness.

What evidence suggests that this trial's treatments could be effective for post-surgery pain in children?

Research has shown that using both acetaminophen and ibuprofen together can effectively reduce pain in children after surgery. In this trial, participants in Group B will receive a combined treatment of acetaminophen and ibuprofen every six hours, while those in Group A will receive an alternating treatment every three hours. Studies have found that ibuprofen relieves pain within two hours, providing quick relief. Another study found that taking acetaminophen before surgery significantly reduces pain afterward. Using these medications together may also lessen the need for stronger painkillers like opioids, which are often used for more severe pain but carry more risks. This combination is considered safe and effective for managing post-surgery pain in children. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children who have undergone general surgery and need pain management. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I have had general surgery, such as for a hernia or appendix removal.

Exclusion Criteria

Patients who are allergic to acetaminophen and/or ibuprofen

Patients being evaluated by SANE or evaluated for nonaccidental trauma

Patients who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either alternating acetaminophen and ibuprofen every 3 hours or combined therapy every 6 hours

72 hours

In-hospital monitoring

Follow-up

Participants are monitored for pain control effectiveness and parent adherence to the treatment plan

1 week

1 follow-up visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen
• Ibuprofen

Trial Overview The study is testing two methods of pain control: alternating doses of acetaminophen and ibuprofen every three hours versus giving both medications together continuously. The goal is to see which method provides better pain relief in children after surgery.

How Is the Trial Designed?

Group I: Group A Experimental Treatment 2 Interventions

Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based.

Group II: Group B Active Control 2 Interventions

Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based.

Acetaminophen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tylenol for:

• Pain relief
• Fever reduction

Approved in European Union as Paracetamol for:

• Pain relief
• Fever reduction

Approved in Canada as Tylenol for:

• Pain relief
• Fever reduction

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Baylor Scott and White Health

Collaborator

Trials

18

Recruited

61,200+

Published Research Related to This Trial

Ibuprofen is an effective analgesic for various pain conditions in children, including musculoskeletal pain, ear pain, and postoperative pain, making it a suitable choice for treating mild to moderate pain.

The safety profile of ibuprofen is favorable, with mild side effects and the lowest gastrointestinal toxicity among NSAIDs, although it should be avoided in dehydrated patients due to potential renal risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of children's inflammatory pain: a clinical and pharmacological overview. Barbagallo, M., Sacerdote, P.[2019]

In a study of 64 children undergoing (adeno)tonsillectomy, all three analgesia protocols showed significant pain levels immediately after surgery, indicating that current pain management strategies may not be sufficient.

Higher doses of paracetamol (500 mg) and the addition of codeine improved pain scores at 3 and 6 hours post-surgery compared to lower doses, suggesting that modifications in analgesic protocols could enhance pain relief after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention and control of pain in (adeno)tonsillectomy]. Boelen-van der Loo, WJ., Driessen, FG.[2020]

In a study of 120 children undergoing adenoidectomy or tonsillotomy, the combination of intravenous ketoprofen and paracetamol significantly reduced the need for rescue analgesia compared to either drug alone, with only 17.5% of the combination group requiring additional pain relief.

Children receiving only paracetamol experienced the highest pain scores and the earliest need for rescue analgesia, indicating that the combination therapy is more effective for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tonsillotomy and adenotonsillectomy in childhood. Study on postoperative pain therapy]. Platzer, M., Likar, R., Stettner, H., et al.[2021]

A fixed-dose combination of acetaminophen (APAP) and ibuprofen (IBP) was found to be well tolerated in a study involving 922 patients, with adverse events similar to or lower than those seen with either drug alone or placebo.

The combination therapy provided superior pain relief compared to monotherapy, while maintaining a strong safety profile without increasing the risk of common adverse events like gastrointestinal issues or postoperative bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated safety analysis of combined acetaminophen and ibuprofen (Maxigesic &#174; /Combogesic&#174;) in adults. Aitken, P., Stanescu, I., Playne, R., et al.[2023]

In a study of 43 children undergoing bilateral myringotomy and tube placement, preoperative administration of either acetaminophen or ibuprofen did not significantly reduce postoperative pain compared to a placebo.

The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores showed no differences among the groups at various time points, indicating that neither analgesic provided effective pain relief in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. Bennie, RE., Boehringer, LA., McMahon, S., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38180091/

Ibuprofen for acute postoperative pain in children Ibuprofen likely results in pain reduction less than two hours postintervention, however, the efficacy might be lower at two hours to 24 hours.

2. brieflands.com brieflands.com/journals/aapm/articles/55806

The Analgesic Efficacy of Preoperative Oral Ibuprofen and ... This study showed that administration of oral acetaminophen 30 minutes preoperatively, resulted in significantly lower pain intensity in ...

3. facs.org facs.org/for-patients/recovering-from-surgery/safe-pain-management/pediatric-pain-control/

Safe and Effective Pain Control After Surgery for Children ... Information on how to provide safe and effective pain control after surgery for children and teens .

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325993/

Enhancing pediatric postoperative pain management Children's postoperative pain is an important issue in perioperative management, with potential impacts on both physiological and psychological development.

5. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2021/07000/comparison_of_monotherapy_versus_combination_of.23.aspx

Comparison of Monotherapy Versus Combination of ... The use of ibuprofen plus propacetamol immediately following laparoscopic hernia repair surgery in children resulted in the reduced use of an opioid drug ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5203901/

How Safe Are Common Analgesics for the Treatment of Acute ... Based on the available evidence, ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids, for the initial ...

7. michigan-open.org michigan-open.org/wp-content/uploads/2024/08/Peds-Surgical-Pain-Management-Toolkit-for-HCP.pdf

2024 Pediatric Surgical Pain Management Toolkit FOR PAIN CONTROL. Acetaminophen (Tylenol®) and ibuprofen (Motrin®) can provide similar pain management to opioids. Specifically, a randomized ...

8. answers.childrenshospital.org answers.childrenshospital.org/pain-medication/

Pain meds 101 - Boston Children's Answers “Acetaminophen is commonly used for mild pain and fever relief. Ibuprofen is a good choice when your child has inflammation from an injury or ...

9. nationwidechildrens.org nationwidechildrens.org/family-resources-education/health-wellness-and-safety-resources/helping-hands/treating-pain-after-outpatient-surgery

Treating Pain After Surgery Your child may get acetaminophen (Tylenol®) and ibuprofen (Motrin® or Advil®). Acetaminophen and ibuprofen will be switched back and forth (alternate) every 3 ...