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. (MAKER)

Vance Thompson Vision

Status and phase: Unknown; Phase 4

Conditions: Anesthesia

Treatments: Drug: Midazolam 3mg Sublingual; Drug: Midazolam/Ketamine HCl 3mg-50mg sublingual; Drug: Ketamine 50mg Sublingual

Study type: Interventional

Funder types: Other

Identifiers

NCT04725747

MAKER

Details and patient eligibility

About

This study is designed to explore the sedative and analgesic effectiveness of the Midazolam/Ketamine melt compared to Midazolam melt alone or Ketamine melt alone in subjects undergoing intraocular surgery.

Full description

Cataract surgery today is a highly effective and efficient procedure, with average times for completion ranging around 15 minutes in duration. Patients undergoing cataract surgery are typically given sedatives and often times pain medication (e.g. opioids) just prior to and during the procedure. The overwhelming majority of patients are given these medications via intravenous administration. The insertion of an IV line has been associated with patient complaints of pain and bruising, and can increase the administrative burden on the clinical staff. In addition to the national crisis surrounding opioid abuse, opioids have many negative side effects during cataract surgery such as respiratory depression, dizziness, nausea, and post- operative vomiting.

To reduce the side effects, improve patient satisfaction, and help surgical center flow the Midazolam/Ketamine melt (MK Melt) has been suggested as an alternative to provide sedation and analgesia in subjects undergoing minor outpatient surgery, such as cataract surgery. The addition of ketamine should provide enough analgesia for the mild discomfort reported during cataract surgery. This study is intended to evaluate the MK Melt and its ability to provide an adequate level of both sedation and intraoperative pain control vs an active control.

Enrollment: 50 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must be male or female, and between the ages of 55-80 years old.
2. Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
3. Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
4. Subjects that are willing to have an IV placed prior to intraocular surgery
5. Subjects undergoing first eye cataract surgery
6. Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.

Exclusion criteria

1. Subjects who have undergone sedation in the past 90 days.
2. Women who are pregnant or lactating at the time of the study.
3. Subjects who do not wish to or cannot comply with study procedures.
4. Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
5. Subjects with history of substance abuse.
6. Subjects that are currently taking a prescription pain medication.
7. Subjects that are not willing to abstain from all over-the-counter pain medication with the exception of 500-1000mg acetaminophen for 24 hours prior to surgery.
8. Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.
9. Subjects with planned use of femtosecond laser, zepto, iris hooks or a malyugin ring during cataract surgery.
10. Subjects with chronic pain rated moderate to severe within the past week.
11. Subjects that have a psychiatric disorder that is currently uncontrolled.
12. Subjects scheduled for same day bilateral or second eye cataract surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups

Midazolam/Ketamine Melt

Experimental group

Description:

One Midazolam/Ketamine 3mg/50mg melt administered sublingually

Treatment:

Drug: Midazolam/Ketamine HCl 3mg-50mg sublingual

Midazolam Melt

Active Comparator group

Description:

Midazolam 3mg melt administered sublingually

Treatment:

Drug: Midazolam 3mg Sublingual

Ketamine Melt

Active Comparator group

Description:

Ketamine 50mg melt administered sublingually

Treatment:

Drug: Ketamine 50mg Sublingual