Ibuprofen + Acetaminophen for Postoperative Pain

Overseen By Keri Discepolo, DDS MPH

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston University

Disqualifiers: Asthma, ASA III or IV, 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: 1 day

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of different pain relief methods for children after dental surgery. It compares three treatments: ibuprofen alone, a combination of ibuprofen and acetaminophen, and alternating between the two. The focus is on reducing pain and discomfort following the procedure. The trial seeks children who require dental surgery under general anesthesia, have no known allergies to the medications, and whose guardians speak English. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, with the goal of understanding how they benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of adverse reactions to NSAIDs or acetaminophen, you cannot participate.

What is the safety track record for these treatments?

Research shows that taking ibuprofen and acetaminophen together can relieve post-surgery pain more effectively than taking either one alone. Studies have found this combination can be as effective, or even better, than some stronger pain medications, like opioids, and it usually has fewer side effects.

When taken together, either by alternating or simultaneously, these two medicines are generally well-tolerated. Many studies found that people experienced fewer unwanted effects compared to other pain relief options. For most people, taking these medicines together is considered safe and effective.

This trial is in a later phase, indicating that earlier tests have already demonstrated the treatment's safety. For those considering joining this trial, existing research suggests the treatment should be well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postoperative pain because they explore different ways to maximize pain relief while minimizing side effects. Unlike the standard approach of using a single medication like ibuprofen, one treatment arm alternates between ibuprofen and acetaminophen every three hours, potentially providing more consistent pain control. Another approach combines both medications at the same time, aiming for a synergistic effect that could enhance pain relief. These strategies could offer patients more effective pain management options following surgery, potentially improving recovery experiences.

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

This trial will compare different methods of administering ibuprofen and acetaminophen for postoperative pain relief. Research has shown that using ibuprofen and acetaminophen together can relieve pain better than using either one alone. Participants in this trial may receive alternating doses of ibuprofen and acetaminophen, which studies suggest provide effective pain relief with fewer side effects compared to other options. Alternatively, some participants will receive both medications simultaneously, a method that can reduce pain more effectively after surgery. Both methods help manage pain without the need for stronger medications. ^{1 2 3 4 6}

Who Is on the Research Team?

Keri Discepolo, DDS MPH

Principal Investigator

BU Goldman School of Dental Medicine, Pediatrics

Are You a Good Fit for This Trial?

This trial is for young children who have undergone dental rehabilitation under general anesthesia 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

Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen

Possess legal guardians proficient in English

I am in good or mild systemic disease state according to ASA.

Exclusion Criteria

I have a serious health condition but am not at immediate risk of death.

I cannot take acetaminophen or ibuprofen due to health reasons.

I have been diagnosed with asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one of three analgesic regimens (ibuprofen monotherapy, alternating ibuprofen and acetaminophen, or combined ibuprofen and acetaminophen) for 24 hours post-surgery

1 day

In-patient during surgery

Follow-up

Participants are monitored for pain and discomfort using the DDQ-8 and FLACC scales

15 days

Day of surgery, 1 day post-surgery, 2 days post-surgery, 15 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen
• Ibuprofen

Trial Overview

The study is testing three different ways to manage pain in kids after dental surgery: just ibuprofen, switching between ibuprofen and acetaminophen, or giving both at regular times. It's a randomized controlled trial at Franciscan Children's Hospital.

How Is the Trial Designed?

Group I: Simultaneous post-operative analgesics Experimental Treatment 2 Interventions

Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.

Group II: Alternating analgesics Experimental Treatment 2 Interventions

Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours.

Group III: Control Standard of Care Active Control 1 Intervention

Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Franciscan Hospital For Children, INC.

Collaborator

Trials

2

Recruited

230+

Published Research Related to This Trial

NSAIDs are generally more effective than paracetamol for pain relief in dental surgery, while their effectiveness is similar in major and orthopedic surgeries, indicating that the choice of pain management may depend on the type of surgery.

Paracetamol is a safer alternative to NSAIDs due to its lower incidence of adverse effects, making it a preferred option for high-risk patients; combining paracetamol with NSAIDs may enhance pain relief, but more research is needed to assess potential side effects from this combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. Hyllested, M., Jones, S., Pedersen, JL., et al.[2022]

In a study of 141 parturients undergoing elective cesarean delivery, intravenous acetaminophen significantly reduced opioid consumption and pain scores compared to no acetaminophen, highlighting its efficacy in postoperative pain management.

However, intravenous acetaminophen did not show a significant advantage over oral acetaminophen in reducing opioid use or improving other outcomes, suggesting that both forms are effective but intravenous administration may be more beneficial when no acetaminophen is used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial. Wilson, SH., Wolf, BJ., Robinson, SM., et al.[2020]

In a study involving 57 patients after root canal treatment, the combination of ibuprofen and acetaminophen provided significantly better pain relief compared to either ibuprofen alone or a placebo.

There was no significant difference in pain relief between the placebo and ibuprofen alone, indicating that the combination therapy is more effective for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Menhinick, KA., Gutmann, JL., Regan, JD., et al.[2022]

Ibuprofen is an effective and safe option for managing mild to moderate postoperative pain, as demonstrated in controlled clinical trials.

In a study involving 120 patients with postoperative orthopedic pain, ibuprofen outperformed acetaminophen-codeine in effectiveness and provided longer-lasting relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. Slavic-Svircev, V., Heidrich, G., Kaiko, RF., et al.[2020]

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]

Citations

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Maxigesic tablets provide superior pain relief after oral surgery to acetaminophen or ibuprofen alone.

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This study will evaluate post-operative pain management in patients undergoing outpatient functional endoscopic sinus surgery. Patients will be randomized into ...

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