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NCT03001843

Ketamine vs Hydromorphone

Completed Phase 4 Results posted Last updated 9 March 2021
What this trial tests

Phase 4 trial testing Ketamine in Laparoscopic Gastric Bypass in 54 participants. Completed in 21 December 2018.

Timeline
22 February 2017
Primary endpoint
21 December 2018
21 December 2018

Quick facts

Lead sponsorUniversity of Florida
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment54
Start date22 February 2017
Primary completion21 December 2018
Estimated completion21 December 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Florida

Who can join

Adults 18 to 65, any sex, with Laparoscopic Gastric Bypass or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Measured Based on Pain Medication Used on a Scale of 0-10 Primary · 48 hours

Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale

GroupValue95% CI
Non-Ketamine1.3± 2.2
Ketamine0.7± 1.5
Length of Stay (Hours) Secondary · 48 hours

Length of stay compared between the 2 groups in hours.

GroupValue95% CI
Non-Ketamine43.6± 20.6
Ketamine39.8± 14.5

Sponsor's own description

This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ketamine

Trials testing the same drug.

Other University of Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03001843.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing