Acetaminophen for Post-Op Pain After Bariatric Surgery

Overseen By Mindy Rodden, PhD, RN, CPNP-AC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it focuses on acetaminophen use after surgery, so it's best to discuss your current medications with the trial coordinators.

What data supports the idea that Acetaminophen for Post-Op Pain After Bariatric Surgery is an effective drug?

The available research does not directly address the effectiveness of acetaminophen for post-op pain after bariatric surgery. However, studies on similar surgeries, like adenotonsillectomy and thyroidectomy, show that acetaminophen can help manage pain. For example, one study found that acetaminophen, when combined with ibuprofen, provided better pain relief for children after tonsil surgery. Another study showed that acetaminophen was effective in controlling pain after thyroid surgery when used with another non-opioid pain reliever. While these studies suggest acetaminophen can be effective for post-surgery pain, they do not specifically address bariatric surgery. ^{1 2 3 4 5}

What safety data exists for acetaminophen in treating post-op pain?

Acetaminophen, also known as paracetamol, is widely used as an analgesic and antipyretic with a well-established safety profile. It is generally well tolerated with minimal side effects when used properly. Intravenous acetaminophen has been shown to be effective in managing pain in various surgical settings and is comparable to other analgesics like propacetamol and pethidine. Serious side effects are rare, but overdose can lead to severe liver damage, which can be mitigated with early treatment using N-acetylcysteine. Acetaminophen is particularly valuable for patients who cannot use NSAIDs, such as those with aspirin sensitivity or at risk of gastrointestinal complications. ^{6 7 8 9 10}

Is the drug acetaminophen a promising option for pain relief after bariatric surgery?

Yes, acetaminophen is a promising option for pain relief after bariatric surgery. Studies show it can help manage pain effectively, reduce the need for stronger painkillers, and lower hospital costs and emergency room visits. ^{11 12 13 14 15}

Research Team

Daniel T Abazia, PharmD, BCPS, CPPS

Principal Investigator

Rutgers University - Ernest Mario School of Pharmacy

Eligibility Criteria

This trial is for adults with morbid obesity who have undergone Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Participants should be in need of postoperative pain management and able to take oral medication. Specific details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am 18 or older and eligible for weight loss surgery.

Exclusion Criteria

I do not have a chronic pain condition or a history of opioid use.

Exclusion of patients from vulnerable populations as outlined by federal guidelines: children, prisoners, pregnant women, and mentally disabled persons.

I am allergic to acetaminophen or its inactive ingredients, or I cannot take pills.

Treatment Details

Interventions

• Acetaminophen (Analgesic)

Trial Overview The study aims to compare the effectiveness of liquid versus pill forms of acetaminophen for managing post-op pain in bariatric surgery patients, considering their unique drug metabolism challenges.

Participant Groups

Group I: Oral acetaminophen - Tablet Experimental Treatment 1 Intervention

Acetaminophen 650 mg tablet by mouth

Group II: Oral acetaminophen - Liquid Experimental Treatment 1 Intervention

Acetaminophen 650 mg liquid by mouth

Acetaminophen is already approved in Canada for the following indications:

Approved in Canada as Tylenol for:

• Pain relief
• Fever reduction

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Rutgers Robert Wood Johnson Medical School

Collaborator

Trials

7

Recruited

18,000+

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 study involving 251 children aged 2-12 years showed that a fixed-dose combination of paracetamol and ibuprofen for pain management after tonsillectomy was well tolerated and effective, with no significant differences in pain scores or rescue medication use between two different dosing groups.

The combination analgesic demonstrated a good safety profile, with the most common side effects being mild (nausea and vomiting), and a low incidence of postoperative bleeding at 4.4%, indicating it can be a reliable option for managing pain at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial. Playne, R., Anderson, BJ., Frampton, C., et al.[2019]

In a study of 180 children undergoing adenoidectomy, oral naproxen (10 mg/kg) significantly reduced the need for rescue analgesics compared to paracetamol (20 mg/kg) and placebo, indicating its efficacy in managing post-operative pain.

The addition of pethidine (1 mg/kg) further decreased the need for rescue fentanyl by 30% and halved the number of doses required, but it also doubled the incidence of post-operative nausea and vomiting (PONV), highlighting a trade-off between pain management and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral naproxen but not oral paracetamol reduces the need for rescue analgesic after adenoidectomy in children. Korpela, R., Silvola, J., Laakso, E., et al.[2013]

In a study of 97 patients undergoing thyroid surgery, ketoprofen provided significantly better pain relief compared to propacetamol alone in the first two hours post-surgery, indicating its greater efficacy as an analgesic.

The combination of propacetamol and ketoprofen did not enhance pain relief compared to ketoprofen alone, suggesting that using both together may not be necessary for effective postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propacetamol and ketoprofen after thyroidectomy. Fourcade, O., Sanchez, P., Kern, D., et al.[2019]

In a study of 120 patients recovering from laparoscopic cholecystectomy, the use of metamizol significantly reduced the consumption of piritramide, an opioid pain medication, compared to other treatments upon discharge from the post-anesthesia care unit.

Overall, while parecoxib showed a lower pain intensity at 24 hours post-surgery, the differences in efficacy among the non-opioid analgesics (parecoxib, metamizol, and paracetamol) were generally weak, indicating that none provided a strong advantage in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, controlled trial on non-opioid analgesics and opioid consumption for postoperative pain relief after laparoscopic cholecystectomy. Abdulla, S., Eckhardt, R., Netter, U., et al.[2022]

Paracetamol, first marketed in the U.K. in 1956, is widely used as an analgesic (pain reliever) and antipyretic (fever reducer).

It has gained popularity among both healthcare professionals and the public as a safer alternative to aspirin for pain and fever management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol. Meredith, TJ., Goulding, R.[2019]

Intravenous paracetamol (1 g) has been shown to provide significantly better pain relief than placebo in adults after surgeries, and it also reduces the need for opioid pain relief, making it an effective first-line treatment.

In pediatric patients, intravenous paracetamol (15 mg/kg) demonstrated similar pain relief and fever reduction compared to propacetamol (30 mg/kg), with a good safety profile and very rare adverse reactions (<1/10,000).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous paracetamol (acetaminophen). Duggan, ST., Scott, LJ.[2022]

Acetaminophen is a well-tolerated first-line pain reliever and fever reducer in children, commonly used in pediatric care with minimal side effects.

The introduction of intravenous acetaminophen in the U.S. provides an important alternative for pediatric patients near end-of-life who may have difficulty with oral intake or rectal administration, enhancing pain management options in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravenous acetaminophen (paracetamol) in a pediatric patient at the end of life: case report. Marks, AD., Keefer, P., Saul, D.[2013]

Paracetamol is a widely used and effective analgesic and antipyretic, with a strong safety profile when used as directed, making it the preferred choice for treating mild to moderate pain in various populations, including children and pregnant women.

Despite concerns about liver toxicity in cases of overdose, early treatment with N-acetylcysteine can prevent serious damage, and ongoing research suggests potential new therapeutic applications for paracetamol beyond pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol: past, present, and future. Prescott, LF.[2022]

Antipyretic analgesics, including aspirin, acetaminophen, and newer 2-arylpropionic acids like ibuprofen and naproxen, are widely used for treating various pain conditions, including those related to infections and minor surgeries.

While many of these medications are considered safe at low doses and available over-the-counter, their varying pharmacodynamic and pharmacokinetic properties mean that they are not equally effective for all types of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[2-Arylpropionic acids. Role in pain therapy]. Brune, K., Hinz, B.[2006]

In a study of 183 patients undergoing laparoscopic Roux-en-Y gastric bypass, the use of scheduled intravenous acetaminophen reduced the demand for narcotic analgesics by 25% and the total dosage required by 20% in the first 24 hours post-surgery.

These findings support the routine use of multimodal analgesia, including intravenous acetaminophen, to minimize narcotic use and its associated side effects in bariatric surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Saurabh, S., Smith, JK., Pedersen, M., et al.[2015]

A systematic review of four randomized controlled trials involving 349 patients found that intravenous (IV) acetaminophen significantly reduced postoperative pain scores and opioid use within 24 hours after bariatric surgery.

Patients receiving IV acetaminophen had a mean difference in pain scores of -0.66 and used 6.44 fewer morphine equivalent doses compared to those receiving a placebo, indicating its efficacy in pain management without affecting the length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Acetaminophen Versus Placebo in Post-bariatric Surgery Multimodal Pain Management: a Meta-analysis of Randomized Controlled Trials. Lee, Y., Yu, J., Doumouras, AG., et al.[2022]

In a randomized controlled trial involving 100 patients undergoing bariatric surgery, the use of IV acetaminophen did not significantly reduce direct hospital costs or postoperative pain scores compared to a control group receiving normal saline.

However, patients in the IV acetaminophen group experienced significantly fewer emergency department visits for abdominal pain and incurred lower indirect costs, suggesting that IV acetaminophen may improve overall patient outcomes and satisfaction despite similar direct costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: a Double-Blind, Prospective, Randomized Trial in a Single Accredited Bariatric Center. El Chaar, M., Stoltzfus, J., Claros, L., et al.[2018]

Administering intravenous paracetamol before surgical incision in bariatric surgery patients significantly reduced postoperative pain, as indicated by lower visual analog scale (VAS) scores compared to administration at the end of the operation.

Patients who received preincisional paracetamol also required fewer opioids and tramadol for pain management post-surgery, highlighting the efficacy of early analgesia in reducing overall pain and opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of timing of intravenous paracetamol on perioperative pain and cytokine levels following laparoscopic bariatric surgery, a randomized controlled trial. Semyonov, M., Bartulovic, A., Cohen, N., et al.[2022]

In a study of 104 patients undergoing bariatric surgery, those who received intravenous acetaminophen (IV APAP) used significantly fewer opioid pain medications postoperatively, with reductions of 21 mg for laparoscopic sleeve gastrectomy (LSG) and 33 mg for laparoscopic Roux-en-Y gastric bypass (LRYGB).

Patients treated with IV APAP also experienced a shorter hospital stay and returned to normal bowel function faster, although their pain scores were similar to those who only received opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing multimodal analgesia with intravenous acetaminophen and opioids in postoperative bariatric patients. Song, K., Melroy, MJ., Whipple, OC.[2014]

References

1. 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]

2. France pubmed.ncbi.nlm.nih.gov

Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Oral naproxen but not oral paracetamol reduces the need for rescue analgesic after adenoidectomy in children. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Propacetamol and ketoprofen after thyroidectomy. [2019]

5. Belgium pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, controlled trial on non-opioid analgesics and opioid consumption for postoperative pain relief after laparoscopic cholecystectomy. [2022]

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

Paracetamol. [2019]

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

Intravenous paracetamol (acetaminophen). [2022]

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

Use of intravenous acetaminophen (paracetamol) in a pediatric patient at the end of life: case report. [2013]

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

Paracetamol: past, present, and future. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[2-Arylpropionic acids. Role in pain therapy]. [2006]

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

Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. [2015]

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

Intravenous Acetaminophen Versus Placebo in Post-bariatric Surgery Multimodal Pain Management: a Meta-analysis of Randomized Controlled Trials. [2022]

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

IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: a Double-Blind, Prospective, Randomized Trial in a Single Accredited Bariatric Center. [2018]

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

The effect of timing of intravenous paracetamol on perioperative pain and cytokine levels following laparoscopic bariatric surgery, a randomized controlled trial. [2022]

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

Optimizing multimodal analgesia with intravenous acetaminophen and opioids in postoperative bariatric patients. [2014]