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Analgesic

Midazolam/Ketamine Melt for Anesthesia (MAKER Trial)

Phase 4
Waitlist Available
Research Sponsored by Vance Thompson Vision
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day post operatively
Awards & highlights

MAKER Trial Summary

This study is evaluating whether a combination of two drugs may be more effective than either drug alone for sedation during eye surgery.

MAKER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of Pain
Level of Sedation
Need for Rescue Medication
Secondary outcome measures
Clinician's Global Impression
Eye Movement During Surgery
Patient Satisfaction
Other outcome measures
Blood pressure changes
Heart rate changes

MAKER Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Midazolam/Ketamine MeltExperimental Treatment1 Intervention
One Midazolam/Ketamine 3mg/50mg melt administered sublingually
Group II: Midazolam MeltActive Control1 Intervention
Midazolam 3mg melt administered sublingually
Group III: Ketamine MeltActive Control1 Intervention
Ketamine 50mg melt administered sublingually

Find a Location

Who is running the clinical trial?

Vance Thompson VisionLead Sponsor
8 Previous Clinical Trials
202 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Randomized, Double-Masked, Controlled, Single Site Investigator Initiated, Exploratory Study of the Midazolam/Ketamine Melt vs Ketamine Melt Alone vs Midazolam Melt Alone in Subjects Undergoing Intraocular Surgery.
John Berdahl, MD 2021. "A Randomized, Double-Masked, Controlled, Single Site Investigator Initiated, Exploratory Study of the Midazolam/Ketamine Melt vs Ketamine Melt Alone vs Midazolam Melt Alone in Subjects Undergoing Intraocular Surgery.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725747.
All > Intraocular Lens
~12 spots leftby Apr 2025
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