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Dextromethorphan for Postoperative Pain

N/A

Recruiting

Research Sponsored by Nathanael Heckmann

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients Age ≥18 planning to undergo total knee arthroplasty

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively and 6, 12, 24, and 48 hours postoperatively

Awards & highlights

Study Summary

This trial is testing whether the drug dextromethorphan can help relieve postoperative pain better than a placebo.

Who is the study for?

This trial is for adults over 18 who are about to have knee replacement surgery and are generally healthy or have mild to moderate systemic disease. It's not for those with a BMI of 35 or higher, a history of opioid abuse, or severe vomiting after past surgeries.Check my eligibility

What is being tested?

The study is testing if Dextromethorphan, commonly used in cough medicines, can help manage pain after knee surgery better than a placebo. Participants will be randomly assigned to receive either the medication or an inactive substance.See study design

What are the potential side effects?

Dextromethorphan may cause dizziness, nausea, restlessness or sleepiness. Since it's being compared with a placebo which has no active ingredients, any side effects would likely be from the Dextromethorphan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older and planning to have knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperatively and 6, 12, 24, and 48 hours postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperatively and 6, 12, 24, and 48 hours postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively and 6, 12, 24, and 48 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-op opioid use

Secondary outcome measures

Postoperative opioid consumption

Pain

Side effects data

From 2019 Phase 3 trial • 156 Patients • NCT03480009

45%

Nausea

23%

Vomiting

19%

Drowsiness

16%

Chills

15%

Dizziness

13%

Diarrhea

10%

Headache

Uterine hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Placebo, Declined Narcotic Prescription

Dextromethorphan, Opted for Narcotic Prescription

Placebo, Opted for Narcotic Prescription

Dextromethorphan, Declined Narcotic Prescription

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DextromethorphanExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dextromethorphan Hydrobromide

2016

Completed Phase 3

~180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nathanael HeckmannLead Sponsor

Media Library

Dextromethorphan Hydrobromide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05278494 — N/A

Postoperative Pain Research Study Groups: Dextromethorphan, Placebo

Postoperative Pain Clinical Trial 2023: Dextromethorphan Hydrobromide Highlights & Side Effects. Trial Name: NCT05278494 — N/A

Dextromethorphan Hydrobromide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05278494 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current population of participants taking part in this research?

"Affirmative. Clinicaltrials.gov documents that this medical trial, initially presented on September 15th 2022 and last updated October 19th 2022, is still actively recruiting research volunteers. This project seeks 160 participants from one site to participate in the study."

Answered by AI

Are there still opportunities for individuals to enroll in this trial?

"Records on clinicaltrials.gov suggest that this research trial is still underway, with the original posting made on September 15th 2022 and most recent revision from October 19th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dextromethorphan for Treatment of Postoperative Pain

Nathanael Heckmann 2022. "Dextromethorphan for Treatment of Postoperative Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05278494.