CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 199 enrolled
Drug / intervention
Sublingual Tabletdrug
Likely dose
Sublingual Tablet 30mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04263909
NCT04263909Phase 4Completed

The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic

Brigham and Women's Hospital·interventional·Posted Feb 11, 2020·Updated Mar 30, 2025

In Brief

A Phase 4 clinical trial evaluating Sublingual Tablet for Spine Fusion and 2 related conditions. Completed, enrolled 199 participants across 1 site.

Detailed Summary

In this study the investigators plan to examine the perioperative use of sufentanil sublingual (SL) in the analgesic regimen for spine surgery, one of the most common surgeries performed in the US. Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. Currently, no data are available for this patient population which routinely experiences moderate to severe acute pain. The investigators will analyze whether sufentanil SL is associated with lower opioid consumption in the post anesthesia care unit and pain scores.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 11, 2020
Enrollment StartDec 1, 2020
Primary CompletionApr 1, 2022
Study CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.4 years ago

Interventions

Sublingual Tabletdrug

sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery