NCT04725747

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Vance Thompson Vision · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Midazolam/Ketamine HCl 3mg-50mg sublingual	Single sublingual administration of Midazolam/Ketamine HCl 3mg-50mg sublingually prior to surgery
DRUG	Midazolam 3mg Sublingual	Single sublingual administration of Midazolam 3mg sublingually prior to surgery
DRUG	Ketamine 50mg Sublingual	Single sublingual administration of Ketamine HCl 50mg sublingually prior to surgery

Timeline

• Start date: 2021-01-25
• Primary completion: 2021-05-30
• Completion: 2021-06-30
• First posted: 2021-01-27
• Last updated: 2021-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study