Nefopam Cream for Burns

Overseen by Edward E Tredget, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Alberta

Must not be taking: Anticholinergics, MAOIs, Tricyclics, others

Disqualifiers: Epilepsy, Diabetes, Renal disease, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a cream called Nefopam to prevent and treat severe scars in adult burn patients. Burn patients often develop difficult-to-treat scars, and Nefopam has shown promise in reducing scar tissue. The cream will be applied to small wounds on the patients' hips, and its effectiveness will be evaluated.

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 are taking certain medications like anticholinergic drugs, sympathomimetic drugs, monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants, you may need to consult with the trial team as these are mentioned in the exclusion criteria.

How is nefopam cream different from other burn treatments?

Nefopam cream is unique because it is a non-opioid, non-steroidal analgesic that works by inhibiting the reuptake of neurotransmitters (chemical messengers in the brain) like serotonin, norepinephrine, and dopamine, which is different from typical burn treatments that often focus on topical antibiotics or pain relief through opioids. ^{1 2 3 4 5}

Research Team

Edward E Tredget, MD

Principal Investigator

University of Alberta

Eligibility Criteria

Adult burn or trauma patients aged 18-65 with certain types of burns, who can understand and follow study procedures. They must have healthy liver function, no history of abnormal scarring, and not be involved in other healing trials. Women should use birth control and not be pregnant. People with well-managed HIV may join after expert consultation.

Inclusion Criteria

Patients who have well controlled HIV as defined by a viral load amount of HIV in the blood that is undetectable i.e. a: viral load less than 40 to 50 copies/ml and cannot be detected by standard tests for HIV, Hep B or Hep C will be included after consultation with an infectious disease expert

Healthy subjects must have ALT and AST < 2 × ULN and TB < ULN at entry

I understand the study, can follow its procedures, and will attend all required visits.

Exclusion Criteria

Currently Subjects involved any other intervention trial(s) where the intervention could possibly affect wound healing to be eligible for enrolment in the SCX-001 (Nefopam) Cream study

I do not have severe lung damage, kidney failure needing dialysis, or unstable blood pressure needing strong medicine.

Subjects who are positive for HIV, hepatitis B or C

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive NEFOPAM Cream or placebo applied to healing deep dermal scratches for 21 days

3 weeks

Daily visits for wound evaluation and treatment application

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including digital photography, Mexameter, and ultrasound evaluations

12 weeks

Visits at Day 27, Day 48, Day 76, and Day 104

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Nefopam Cream (Other)
• Placebo (Vehicle) (Other)

Trial Overview The trial is testing Nefopam Cream's ability to prevent or reduce scarring in burn patients by comparing it to a placebo cream. Patients will receive both treatments on different sides of the hip and undergo regular assessments including photographs, ultrasound for scar thickness, color measurements, and personal scar evaluations.

Participant Groups

Group I: Nefopam Experimental Treatment 1 Intervention

NEFOPAM 3% cream will be applied topically to healing deep dermal scratches in the lateral hip of burn patients daily (twice) for 3 weeks during the proliferative phase of wound healing.

Group II: Placebo Placebo Group 1 Intervention

This will work as a placebo for the experimental drug.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Findings from Research

In a study involving 90 patients, nefopam was found to provide comparable pain relief to pentazocine for postoperative pain, but with a longer duration of action.

Nefopam had a lower impact on respiratory function compared to pentazocine, making it a safer option for patients, although it was associated with increased drowsiness and sweating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nefopam in postoperative pain. Calmi, D., Pagnoni, B., Tiengo, M., et al.[2013]

A study involving 12 healthy male subjects found that both the reference and test formulations of nefopam tablets had similar pharmacokinetic profiles, indicating comparable bioavailability after a single 30 mg dose.

The maximum plasma concentration (C(max)) and the time to reach maximum concentration (T(max)) were nearly identical for both formulations, suggesting that they can be considered equivalent in terms of how the body absorbs and processes the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of pharmacokinetics and comparative bioavailability of nefopam 30 mg tablets in twelve fasting healthy Pakistani male young subjects: single-dose, randomized, two-period, two-treatment and two-way cross-over design. Ahmad, M., Yaqoob, M., Murtaza, G.[2013]

A systematic review found no clinical studies demonstrating the efficacy of oral nefopam for treating acute postoperative pain, indicating that its use for this purpose is not justified.

Due to the lack of evidence supporting nefopam's analgesic properties in postoperative settings, further evaluation of its use in other pain conditions is necessary, especially given the availability of other effective pain relief options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single dose oral nefopam for acute postoperative pain in adults. Kakkar, M., Derry, S., Moore, RA., et al.[2022]

Nefopam (NFP) is a non-opioid analgesic that works through mechanisms similar to triple neurotransmitter reuptake inhibitors, making it particularly effective for treating neuropathic pain.

To minimize side effects like nausea and dizziness, NFP should be administered intravenously in doses of 20 mg over 15-20 minutes or as a continuous infusion of 60-120 mg per day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rediscovery of nefopam for the treatment of neuropathic pain. Kim, KH., Abdi, S.[2022]

In a study of 90 patients undergoing laparoscopic cholecystectomy, nefopam combined with fentanyl significantly reduced pain levels compared to fentanyl alone, particularly at 10 minutes, 2 hours, and 6 hours post-surgery.

The combination of fentanyl with 20 mg of nefopam not only provided effective pain relief but also resulted in lower nausea and shivering compared to higher doses of nefopam and fentanyl alone, indicating a safer profile for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic effect of nefopam with fentanyl at the end of laparoscopic cholecystectomy. Lee, JH., Kim, JH., Cheong, YK.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Nefopam in postoperative pain. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Study of pharmacokinetics and comparative bioavailability of nefopam 30 mg tablets in twelve fasting healthy Pakistani male young subjects: single-dose, randomized, two-period, two-treatment and two-way cross-over design. [2013]

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

Single dose oral nefopam for acute postoperative pain in adults. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Rediscovery of nefopam for the treatment of neuropathic pain. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

The analgesic effect of nefopam with fentanyl at the end of laparoscopic cholecystectomy. [2022]