Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy

PHASE3CompletedINTERVENTIONAL
Enrollment

341

Participants

Timeline

Start Date

December 14, 2022

Primary Completion Date

September 6, 2024

Study Completion Date

September 6, 2024

Conditions
Pain, Postoperative
Interventions
DRUG

Ketorolac Tromethamine

Ketorolac tromethamine, alcohol free formulation, 1.0 mg/mL in saline solution (\~0.9% NaCl) adjusted to a pH of \~7.4. Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL of NTM-001).

DRUG

Morphine Sulfate

Morphine single use vials at 4 mg/mL, filled with 1 mL.

OTHER

Intravenous Placebo for NTM-001

Placebo alcohol free saline solution (\~0.9% NaCl; matching active NTM-001). Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL Placebo solution).

OTHER

IV Placebo for Morphine

Placebo single use vials with saline (matching active morphine).

Trial Locations (10)

21122

Chesapeake Research, Pasadena

45417

Midwest Clinical Research Center, Dayton

66212

Dr. Vince Clinical Research, Overland Park

74104

The Orthopedic Center, Tulsa

78229

Endeavor Clinical Trials, San Antonio

85351

Sun City Clinical Research, Sun City

91304

Alliance Research Intitute, Canoga Park

91767

Pasadena Clinical Trials, Pomona

93301

Trovare Clinical Research, Bakersfield

07675

Curalta Clinical Trials, Westwood

Sponsors
All Listed Sponsors
lead

NEMA Research, Inc.

INDUSTRY

NCT05324358 - Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy | Biotech Hunter | Biotech Hunter