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

Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03653520
Enrollment
651
Registered
2018-08-31
Start date
2017-06-28
Completion date
2017-11-04
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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.

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

DRUGDiazepam

5 or 10mg

DRUGTramadol

50mg or 100mg

DRUGOndansetron

1 or two tabs

DRUGMKO melt

1 or 2 MKO melts

Sponsors

Avanti Anesthesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

The surgeon was not aware which medication the patient received

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patient who needed additional IV medication for cataract surgery1 dayPatients who require IV medications for self-reported pain or anxiety during surgery.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026