← Back to Search

Nonsteroidal Anti-inflammatory Drug

Continuous IV Infusion of Ketorolac for Postoperative Pain

Phase 3

Recruiting

Research Sponsored by NEMA Research, Inc.

Eligibility Criteria Checklist

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

Must have

Scheduled to undergo primary unilateral first metatarsal bunionectomy

Body weight ≥50 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 24 hours after start of administration

Awards & highlights

Study Summary

This trialtests the effectiveness and safety of a new drug (NTM-001) to treat post-op pain after bunionectomy surgery, comparing it to placebo and an active comparator.

Who is the study for?

Adults aged 18-64 scheduled for bunionectomy surgery, with good physical status (ASA ≤2), and women must be non-fertile or use birth control. Excludes those with peptic ulcers, NSAID allergies, bleeding disorders, severe kidney/liver issues, certain chronic diseases, drug abuse history, or recent experimental drug use.Check my eligibility

What is being tested?

The trial tests NTM-001's effectiveness in managing post-surgery pain compared to a placebo and morphine. It's double-blind and includes multiple centers. Participants won't know if they're getting the real medicine or a dummy version.See study design

What are the potential side effects?

Possible side effects may include gastrointestinal issues due to ketorolac (like stomach pain or ulcers), allergic reactions similar to other NSAIDs, increased risk of bleeding, and typical opioid-related effects from morphine such as drowsiness or constipation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for surgery to correct a bunion on my foot.

Select...

My body weight is 50 kg or more.

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 24 hours after start of administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 24 hours after start of administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 24 hours after start of administration for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Summed Pain Intensity Difference (SPID24)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: NTM-001 Treatment ArmExperimental Treatment2 Interventions

NTM-001 loading dose of 12.5 mg administered over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mg/h for 24h, by a pre-programmed infusion pump. Subjects will also receive placebo to IV Morphine (injections).

Group II: Morphine Treatment ArmActive Control2 Interventions

A single IV morphine bolus (4 mg) every 4h for up to 24h. Subjects will also receive placebo to NTM-001.

Group III: Placebo Treatment ArmPlacebo Group2 Interventions

Subjects randomized will receive placebos of both active treatments concomitantly. Placebo to NTM-001: Placebo "loading dose" applied over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mL/h for 24h by a pre-programmed infusion pump. Placebo to IV morphine injections: A single IV placebo bolus every 4h for up to 24h.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NEMA Research, Inc.Lead Sponsor

16 Previous Clinical Trials

40,597 Total Patients Enrolled

Frequently Asked Questions

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

Are participants aged less than 35 years old permitted to enter this investigation?

"This trail is open to patients ranging from 18 - 64 years old. 63 studies are available for those under the age of majority and 342 exist for seniors over 65."

Answered by AI

Can members of the public enroll in this research at present?

"Clinicaltrials.gov data confirms that this clinical trial is actively looking to recruit patients; the study was first posted on November 15th 2022 and subsequently edited in December 28th 2022."

Answered by AI

Has the NTM-001 Treatment Arm been granted authorization by the FDA?

"Our team has rated the safety of NTM-001 Treatment Arm to be a 3 on our scale due to evidence from Phase 3 trials that supports its efficacy and multiple reports confirming its security."

Answered by AI

How many healthcare facilities are carrying out this research project?

"This trial is running at 6 distinct research centres, including NextStage Clinical Research- The Orthopedic Center in Jenks, First Surgical (ERG) in Bellaire and HD Research in Houston. Remaining sites are located across the country."

Answered by AI

Who fulfills the eligibility criteria to join this trial?

"This clinical trial is seeking 360 participants suffering from postoperative pain, aged 18 to 64. Furthermore, they must meet the requisite criteria of Physical status rated as ≤2 on the American Society of Anesthesiologists (ASA) rating scale (Owens, Felts et al. 1978), Scheduled for primary unilateral first metatarsal bunionectomy; Women that are either postmenopausal or practicing a form of effective contraception and men and women with body weight ≥50 kg who are willing to complete all study procedures including training on pain scales, follow instructions, communicate meaningfully with study personnel and return for all visits listed in the"

Answered by AI

How many test subjects are participating in this medical experiment?

"To effectively conduct this clinical trial, 360 qualified participants are required. Specialized medical centres such as NextStage Clinical Research- The Orthopedic Center in Jenks, Oklahoma and First Surgical (ERG) in Bellaire, Texas have been identified to recruit patients from."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05324358.