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

Trial Summary

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 data supports the effectiveness of the drug combination of ibuprofen and acetaminophen for postoperative pain?

Research shows that combining ibuprofen and acetaminophen can provide better pain relief after surgery compared to using either drug alone. This combination has been approved for use in adults for managing postoperative pain, indicating its effectiveness. ^{1 2 3 4 5}

Is the combination of ibuprofen and acetaminophen safe for postoperative pain?

Research shows that ibuprofen and acetaminophen are generally safe for treating postoperative pain. A study found that ibuprofen is effective and safe for mild to moderate pain, and acetaminophen is also considered safe in various pain models. The combination of these two drugs has been approved by the FDA for postoperative pain, indicating its safety. ^{2 4 6 7 8}

How does the drug combination of ibuprofen and acetaminophen differ from other treatments for postoperative pain?

The combination of ibuprofen and acetaminophen in a single tablet is unique because it provides better pain relief than using either drug alone, and it has been shown to reduce the need for opioids, which can have more side effects. This fixed-dose combination was approved by the FDA for postoperative pain, offering a more effective and potentially safer alternative to traditional pain management options. ^{1 2 4 9 10}

What is the purpose of this trial?

The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures. The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.

Research Team

Keri Discepolo, DDS MPH

Principal Investigator

BU Goldman School of Dental Medicine, Pediatrics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. England 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. [2022]

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

Efficacy and Safety of Ibuprofen Plus Paracetamol in a Fixed-Dose Combination for Acute Postoperative Pain in Adults: Meta-Analysis and a Trial Sequential Analysis. [2021]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Evaluation of the efficacy of paracetamol as a component of postoperative combined analgesia in children]. [2013]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The PANSAID randomized clinical trial: A pre-planned 1-year follow-up regarding harm. [2021]

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

Ibuprofen in the treatment of postoperative pain. [2020]

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

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]

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

A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-controlled, factorial study. [2013]

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

Median effective dose (ED₅₀) of paracetamol and morphine for postoperative pain: a study of interaction. [2018]