Medrol Dosepak for Foot and Ankle Surgery

Recruiting at 1 trial location

Overseen By Jason Bariteau, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Disqualifiers: Severe heart disease, Renal failure, Liver dysfunction, Diabetes, 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: 3

Duration: 1 week

180 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. It's best to discuss this with the study team or your doctor.

Is Medrol Dosepak generally safe for humans?

Licensed drugs like Medrol Dosepak can cause unexpected side effects, but official drug package inserts list known adverse reactions from clinical trials and postmarketing surveillance, helping to ensure safe use. ^{1 2 3 4 5}

How does the drug Medrol Dosepak differ from other treatments for foot and ankle surgery?

Medrol Dosepak is unique because it provides a specific schedule of oral corticosteroids (a type of anti-inflammatory drug) that helps reduce swelling and pain after surgery, which may not be the focus of other treatments for foot and ankle surgery. ^{6 7 8 9 10}

What is the purpose of this trial?

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries. The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

Research Team

Rishin Kadakia, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for patients undergoing foot and ankle surgeries who are looking to manage pain, nausea, and reduce opioid use post-surgery. Participants should not have conditions that could complicate wound healing or be at risk of tendon injuries.

Inclusion Criteria

I am an Emory Orthopedic patient having foot or ankle surgery.

Exclusion Criteria

I do not have severe heart, kidney, liver issues, stomach ulcers, diabetes, arthritis, or mental health conditions that affect how I feel pain.

Pre-existing immune suppression

History of alcohol or medical abuse, including prior opioid abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-day low-dose methylprednisolone course starting on the day of surgery

1 week

1 visit (in-person) for surgery

Post-operative Monitoring

Participants record pain, nausea, and opioid consumption in a pain journal for 7 days post-surgery

1 week

1 visit (in-person) at 2-week post-op appointment

Follow-up

Participants are monitored for complications and patient-reported outcomes at post-operative appointments

6 months

Multiple visits (in-person) at 1.5, 3, and 6 months

Treatment Details

Interventions

• Medrol Dosepak

Trial Overview The study tests a 6-day course of low-dose methylprednisolone (Medrol Dosepak) against standard care to see if it can decrease pain, nausea, and the need for opioids after surgery. It also looks at surgical complications and patient satisfaction.

Participant Groups

Group I: Medrol Experimental Treatment 2 Interventions

The group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day. Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications.

Group II: Standard of Care Active Control 1 Intervention

Each subject will receive the standard pain regime of both surgeons. This includes a nerve block before surgery for pain prevention. While in surgery, the subject will receive 10 mg of dexamethasone intravenously. Post-surgery, each subject will be instructed to take vitamin C for nerve pain and vitamin D for bone healing. They will also be provided with a prescription of aspirin for deep vein thrombosis (DVT) prophylaxis, ondansetron (Zofran) for nausea, and Colace for constipation relief. Both groups will receive a prescription of 20 5 mg hydrocodone pills to be taken as needed for pain, 1 every 6 hours Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. Journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. Subjects will also be evaluated for complications

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Findings from Research

In a study of 140 critical-dose drugs, it was found that the maximum recommended therapeutic doses (MRTD) from the FDA and the Summary of Product Characteristics (SPC) often differed, with 37% being similar, 32% higher, and 31% lower, highlighting inconsistencies in dosing guidelines.

The analysis of 633 electronically prescribed drugs revealed that prescription rates of excessive doses were significantly higher when using FDA MRTD values (6.1%) compared to SPC values (2.5%), indicating the need for careful selection of dosing databases to prevent overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection and prevention of prescriptions with excessive doses in electronic prescribing systems. Seidling, HM., Al Barmawi, A., Kaltschmidt, J., et al.[2018]

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

A new multi-stage Bayesian hierarchical Poisson model was developed to estimate adverse event rates in randomized controlled trials using the MedDRA coding system, which helps organize and analyze reported adverse events more effectively.

The model improves the analysis of rare adverse events by aggregating data at higher levels within the MedDRA structure, demonstrating better performance in simulations and real-world applications compared to existing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials. Revers, A., Hof, MH., Zwinderman, AH.[2022]

The safety profile of a drug post-registration is primarily informed by spontaneous reports from healthcare professionals, highlighting the importance of ongoing monitoring after a drug is approved.

This article focuses on analyzing adverse drug reactions reported to the Regional Centre of Monitoring Adverse Drug Reactions in Poznań, emphasizing the need for systematic evaluation of these reports to ensure drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. Jabłecka, A., Korzeniowska, K.[2013]

A new ontology model was developed to systematically organize and represent adverse drug reactions (ADRs) from package inserts of quinolone drugs, which included data from 165 package inserts and resulted in a comprehensive ADR ontology with 2879 classes and 15,711 semantic relations.

This structured approach allows for better identification and analysis of ADRs, enhancing understanding and safety in medication prescriptions, and could potentially reduce morbidity and healthcare costs associated with unexpected drug reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study. Li, X., Lin, X., Ren, H., et al.[2021]

In a study involving 416 asthmatic patients, switching from fluticasone/salmeterol to extrafine beclometasone/formoterol maintained lung function and asthma control over a 12-week period, demonstrating clinical equivalence between the two treatments.

Both treatments showed no significant differences in pre-dose lung function (FEV1) and maintained asthma control, with no safety issues reported, indicating that the switch is safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Barnes, N., van Noord, JA., Brindicci, C., et al.[2017]

The Airmax inhaler, utilizing the X-ACT system, delivers consistent and accurate doses of formoterol, achieving 97% and 100% of the labeled dose for 6 and 12 microg strengths, respectively, across a large sample size (n=140 for 6 microg and n=440 for 12 microg).

The inhaler produces a fine particle fraction (FPF) of 44.4%, indicating a significant proportion of the aerosolized drug is in a respirable size, which enhances the efficacy of the medication for patients with respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of formoterol from a novel multi-dose inhaler Airmax. Zeng, XM., Jones, S., O'Leary, D., et al.[2019]

In a randomized, double-blind trial involving 94 patients with acute asthma, the addition of flunisolide to salbutamol significantly improved lung function (FEV1 and PEFR) compared to salbutamol alone, particularly at 90, 120, 150, and 180 minutes after treatment.

The study suggests that high and cumulative doses of inhaled flunisolide are effective for patients with prolonged asthma symptoms (over 24 hours) before arriving at the emergency room, indicating its potential as a beneficial therapy in acute asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled flunisolide for acute severe asthma. Rodrigo, G., Rodrigo, C.[2021]

A study involving 50 medical personnel showed that their skills and knowledge in using newer dry powder inhalers (budesonide and salmeterol) were significantly lower than for conventional metered-dose inhalers (MDIs), with average demonstration scores of only 49.9% for budesonide and 64.2% for salmeterol.

The findings indicate a critical gap in training among medical personnel, particularly among registered nurses and medical residents, which likely contributes to patients' difficulties in using inhalers correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does introduction of new "easy to use" inhalational devices improve medical personnel's knowledge of their proper use? Chopra, N., Oprescu, N., Fask, A., et al.[2015]

In a 4-month study involving 2179 adult asthma patients, the extrafine formulation of beclomethasone/formoterol (BDP/F pMDI HFA) significantly improved asthma control, as shown by a decrease in the Asthma Control Questionnaire score from 1.62 to 0.94 (p < 0.001).

Patients reported better compliance with their medication, with those forgetting to take their medication dropping from 49.7% to 27.1% (p < 0.001), and most patients expressed satisfaction with the inhaler device, preferring it over dry powder inhalers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of asthma control in adult patients using extrafine inhaled beclomethasone/formoterol fixed combination as maintenance therapy as well as maintenance and reliever therapy - CONTROL study. Dębowski, T., Marko, M., Rogala, B., et al.[2023]

References

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

Detection and prevention of prescriptions with excessive doses in electronic prescribing systems. [2018]

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

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]

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

BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA&#174;-Coded Adverse Events in Randomized Controlled Trials. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. [2013]

5. Canada pubmed.ncbi.nlm.nih.gov

Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study. [2021]

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

Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Delivery of formoterol from a novel multi-dose inhaler Airmax. [2019]

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

Inhaled flunisolide for acute severe asthma. [2021]

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

Does introduction of new "easy to use" inhalational devices improve medical personnel's knowledge of their proper use? [2015]

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

Improvement of asthma control in adult patients using extrafine inhaled beclomethasone/formoterol fixed combination as maintenance therapy as well as maintenance and reliever therapy - CONTROL study. [2023]