Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Overview

The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.

Full Title of Study: “Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: November 2, 2017

Detailed Description

The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).

Interventions

  • Drug: Diazepam
    • 5 or 10mg
  • Drug: Tramadol
    • 50mg or 100mg
  • Drug: Ondansetron
    • 1 or two tabs
  • Drug: MKO melt
    • 1 or 2 MKO melts

Arms, Groups and Cohorts

  • Active Comparator: diazepam only (group 1)
    • Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation
  • Active Comparator: diazepam/tramadol/ondansetron (group 2)
    • Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation
  • Experimental: MKO only (group 3)
    • Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation

Clinical Trial Outcome Measures

Primary Measures

  • Number of patient who needed additional IV medication for cataract surgery
    • Time Frame: 1 day
    • Patients who require IV medications for self-reported pain or anxiety during surgery.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center

Exclusion Criteria

  • Age <18 years
  • Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness
  • Allergy to a medication in protocol

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Avanti Anesthesia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maggie Jeffries, Principal Investigator – Avanti Anesthesia
  • Overall Official(s)
    • Maggie Jeffries, MD, Principal Investigator, Avanti Anesthesia

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