Dextromethorphan for Treatment of Postoperative Pain

N

Nathanael Heckmann

Status

Enrolling

Conditions

Post-operative Pain

Treatments

Drug: Placebo
Drug: Dextromethorphan Hydrobromide

Study type

Interventional

Funder types

Other

Identifiers

NCT05278494
HS-22-00191

Details and patient eligibility

About

A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain

Full description

There is extensive preclinical evidence that dextromethorphan has an analgesic effect in patients with pain of traumatic origin. The primary objective is to of this study is to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing total knee arthroplasty (TKA). This is a single-institution, multi-dose, randomized, placebo-controlled, trial to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing TKA. Male and/or female patients will be randomized to either dextromethorphan treatment group (n = 80) or placebo group (n= 80). Patients will receive 60 mg oral dextromethorphan (or matching placebo) preoperatively, as well as 30 mg 8- and 16-hours postoperatively.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

  • Patients Age ≥18 planning to undergo total knee arthroplasty
  • ASA classes I - III

Main Exclusion Criteria:

  • BMI ≥ 35
  • History opioid abuse
  • History of intractable vomiting after previous surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups, including a placebo group

Dextromethorphan
Experimental group
Treatment:
Drug: Dextromethorphan Hydrobromide
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Pui Yan, MS

Data sourced from clinicaltrials.gov

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