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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug combination of acetaminophen and ibuprofen for post-surgery pain in children?

Research indicates that using a combination of ibuprofen and acetaminophen can provide greater pain relief than using either drug alone for managing various painful conditions in children, including post-surgery pain. ^{1 2 3 4 5}

Is the combination of acetaminophen and ibuprofen safe for children after surgery?

Acetaminophen and ibuprofen are generally safe for children when used at recommended doses. Ibuprofen has mild side effects and is safe for mild to moderate pain, but should be avoided in children with dehydration or kidney issues. Combining acetaminophen and ibuprofen can provide better pain relief without exceeding safe dose limits. ^{3 6 7 8 9}

How does the drug combination of acetaminophen and ibuprofen differ from other treatments for post-surgery pain in children?

The combination of acetaminophen and ibuprofen for post-surgery pain in children is unique because it combines two commonly used pain relievers that work in different ways: acetaminophen reduces pain and fever, while ibuprofen also reduces inflammation. This dual action may provide more comprehensive pain relief compared to using either drug alone. ^{2 4 6 10 11}

What is the purpose of this trial?

To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Serbia pubmed.ncbi.nlm.nih.gov

[Relief of pain after tonsillo-adenoidectomy in preschool-age children ]. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Prevention and control of pain in (adeno)tonsillectomy]. [2020]

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

Comparison of Oral Ibuprofen and Acetaminophen with Either Analgesic Alone for Pediatric Emergency Department Patients with Acute Pain. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Tonsillotomy and adenotonsillectomy in childhood. Study on postoperative pain therapy]. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Oral morphine for pain management in paediatric patients after tonsillectomy and adenotonsillectomy. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

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

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

An integrated safety analysis of combined acetaminophen and ibuprofen (Maxigesic &#174; /Combogesic&#174;) in adults. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Supratherapeutic utilization of paracetamol versus ibuprofen among [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Care in the use of ibuprofen as an antipyretic in children. [2013]

10. England pubmed.ncbi.nlm.nih.gov

IV perioperative ketoprofen in small children during adenoidectomy. [2019]

11. France pubmed.ncbi.nlm.nih.gov

Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. [2019]