NCT02466022

Does Single Dose Dexmedetomidine for Procedural Sedation Reduce Post-operative Pain in Total Knee Arthroplasty? A Randomized Control Study

Completed Phase 3 Last updated 14 June 2016

What this trial tests

Phase 3 trial testing Dexmedetomidine in Post-operative Pain for Total Knee Arthroplasty in 54 participants. Completed in 1 November 2015.

Timeline

1 June 2015

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	University of Saskatchewan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	54
Start date	1 June 2015
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	1 location across Canada

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Bupivicaine — full drug profile →
• Normal Saline
• Fentanyl (fentanyl) — full drug profile →
• Midazolam (midazolam) — full drug profile →

Conditions studied

• Post-operative Pain for Total Knee Arthroplasty — all drugs for Post-operative Pain for Total Knee Arthroplasty →

Sponsor

University of Saskatchewan

Who can join

18 and older, any sex, with Post-operative Pain for Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Total Morphine Consumption
  Time frame: 24 Hours
  mg of IV morphine administered via Patient Controlled Analgesia. Patient will be told to deliver morphine dose for pain =\>4 from a numerical rating scale for pain from 0 to 10

Sponsor's own description

Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control, with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine has been used with a large loading dose and infusion, which has been known to cause dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine produces less negative side-effects, but still effective sedation and reduced post-operative pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but only a few studies exist investigating its benefits when administered for sedation purposes with spinal anesthesia, and no studies primarily examine post-operative opioid consumption. The investigators hypothesize that single dose dexmedetomidine for procedural sedation will reduce opioid consumption after total knee arthroplasty (TKA).

Publications & conference data

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