Clinical Trials Directory

Trials / Completed

CompletedNCT05259098

Morphine vs Sufentanil PCA: Same Same or Different?

"Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Hospital Central do Funchal · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose. In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System with intravenous PCA Morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.

Detailed description

In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System (15mcg per tablet, 20 minutes lockout) with intravenous PCA Morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour. 45 patients capable of comply a PCA regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. During the first 48 hours, it was accessed daily pain scores, PCA use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. Brief Pain Inventory was performed before surgery and 4 months later.

Conditions

Interventions

TypeNameDescription
DRUGSufentanil Sublingual Tablet SystemSufentanil Sublingual Tablet System is a sublingual opioid patient controlled analgesia system. It was used for postoperative analgesia after surgery associated with moderate to severe pain.
DRUGIntravenous Patient-Controlled Analgesia with morfineIntravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.

Timeline

Start date
2019-10-01
Primary completion
2020-06-30
Completion
2020-10-31
First posted
2022-02-28
Last updated
2022-02-28

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT05259098. Inclusion in this directory is not an endorsement.