A double-blinded, placebo-controlled, randomized study to evaluate the efficacy of perioperative dextromethorphan compared to placebo for the treatment of postoperative pain: a study protocol

Table 1 Study calendar: Screening activities may be performed any day up to and including day 1 on study, but will always be performed prior to administration of study drug or placebo. POD1 = post-op day 1; KOOS JR = Knee injury and Osteoarthritis Outcome Score for Joint Replacement; PROMIS = Patient-Reported Outcomes Measurement Information System; 1 = As clinically indicated. A symptom-directed physical exam to be completed for AEs which are at least possibly related to study treatment

Study procedure	Screening (day − 90)	Day 1				48 ± 4 h	Week 6 ± 3	Final (3–6 months)
Study procedure	Screening (day − 90)	Pre-op	8 ± 4 h	16 ± 4 h	24 ± 4 h	48 ± 4 h	Week 6 ± 3	Final (3–6 months)
Screening/administrative
Sign main informed consent form	x
Inclusion/exclusion criteria	x
Medical history and demographics	x
Study drug administration
Administration of study drug or placebo		x	x	x
Safety assessments
Physical examination	x	x	x¹	x¹	x¹	x¹	x	x
Vital signs	x	x	x¹	x¹	x¹	x¹	x	x
Prior therapies	x
Physical measurements	x
Hematology	x
Serum chemistry	x
Outcome evaluations
Post-op opioid use					x	x	x	x
VAS-pain with movement	x		x	x	x	x	x	x
VAS-pain at rest	x		x	x	x	x	x	x
KOOS JR	x						x	x
PROMIS-29	x						x	x
Clinical anchors							x	x
Adverse events			x	x	x	x	x	x

ISSN: 1745-6215