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Sublingual Tablet for Postoperative Pain

Phase 4
Waitlist Available
Led By Richard D. Urman, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 min after pacu arrival
Awards & highlights

Study Summary

This trial will examine the use of sufentanil to ease pain for those undergoing spine surgery.

Eligible Conditions
  • Postoperative Pain
  • Opioid Use Disorder
  • Spinal Fusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 min after pacu arrival
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 min after pacu arrival for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Pain Scores - PACU
Postoperative Pain Scores - post-anesthesia care unit (PACU)
Secondary outcome measures
Length of stay in the PACU
Length of stay on the Inpatient floor
Opioid consumption - Inpatient Floor
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: sufentanil SL armExperimental Treatment1 Intervention
Each patient will receive 30mcg of sufentanil SL prior to extubation in the operating room, and then as needed in the recovery room, guided by pain scores.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,800 Total Patients Enrolled
2 Trials studying Postoperative Pain
164 Patients Enrolled for Postoperative Pain
Richard D. Urman, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
32 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results is this clinical trial trying to achieve?

"The primary assessment of this trial's success is the participants' Postoperative Pain Scores in the post-anesthesia care unit, measured over a 24 hour period. Other metrics include the Sedation level on PACU (measured from 0 to 10), Inpatient Floor Pain scores (assessed via NRS scale), and Length of stay in PACU until discharge for transfer."

Answered by AI

What are the eligibility requirements for participating in this clinical trial?

"An individual's eligibility for this clinical trial hinges on the fact that they must be in a state of postoperative pain and between 18-85 years old. This research is currently accepting a maximum of 30 participants."

Answered by AI

How many subjects are engaged in this experiment?

"Recruitment for this study has been suspended. The trial was published on December 1st, 2020 and the last update took place November 21st of 2022. Currently there are 618 studies actively looking for volunteers with pain or postoperative issues as well as 17 trials involving Sublingual Tablets that require participants."

Answered by AI

Are volunteers currently needed for this research endeavor?

"The trial's listing on clinicaltrials.gov verifies that patient recruitment has been suspended for this particular medical investigation; the study was first posted in December 1st 2020, and last amended November 21st 2022. However, 635 other trials are actively seeking patients at present."

Answered by AI

Are there any precedents for Sublingual Tablet in medical research?

"Currently, 17 clinical trials for Sublingual Tablet are underway with 5 of these trials in Phase 3. Additionally, 25 medical centres worldwide are conducting studies on the tablet form medication, among them being several sites located in Wuhan, Hubei."

Answered by AI

In what scenarios is a Sublingual Tablet usually administered?

"Traditionally, the sublingual tablet is utilized to manage pain. However, it can also be prescribed for general anesthesia and short-term opioid analgesia; plus, this medication may also be applied during intubation procedures."

Answered by AI

Has the Sublingual Tablet been approved by the relevant government agencies?

"There is a plethora of evidence backing the safety profile of Sublingual Tablet and thus, it was given a score of 3."

Answered by AI

Is the eligibility cutoff for this trial more than twenty years of age?

"To be eligible for this clinical trial, patients must fall within the age range of 18 and 85. Additionally, 84 trials are available for those under 18 years old and 500 studies exist for people older than 65."

Answered by AI
~7 spots leftby Apr 2025