Trial · NCT04263909
The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients
NCT04263909, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2025-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients. Trials, record NCT04263909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04263909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients
- NCT number
- NCT04263909
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 199 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Spine Fusion, Pain, Postoperative, Opioid Use
- Interventions
- Sublingual Tablet
- First posted
- 2020-02-11
- Last updated
- 2025-03-30
- Results first posted
- 2025-03-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit | Up to 120 minutes after arrival to PACU | pain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain) |
| Secondary | Opioid Consumption - PACU | up to 120 min after arrival to the post anesthesia care unit (PACU) | total amount of opioids (in morphine milligram equivalents) used |
| Secondary | Opioid Consumption - Inpatient Floor | up to 48 hours, from arrival to inpatient floor until discharge home | total amount of opioids (in morphine milligram equivalents) used |
| Secondary | Postoperative Pain Scores - Inpatient Floor | up to 48 hours, from arrival to inpatient floor until discharge home | pain scores as reported by the patient using NRS (numerical rating scale) 0 (no pain)-10 (worst possible pain) |
| Secondary | Length of Stay in the PACU | up to 24 hours | the amount of time (in minutes) the patient stayed in the PACU until the patient was signed out as ready to be transferred to inpatient floor |
| Secondary | Length of Stay on the Inpatient Floor | up to 30 days | the amount of time (in days) the patient stayed on the inpatient floor until the patient was discharged to home |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit | Up to 120 minutes after arrival to PACU | Pain score NSR | MEAN | |
| SECONDARY | Opioid Consumption - PACU | up to 120 min after arrival to the post anesthesia care unit (PACU) | morphine milligram equivalents | MEAN | |
| SECONDARY | Opioid Consumption - Inpatient Floor | up to 48 hours, from arrival to inpatient floor until discharge home | morphine milligram equivalents | MEAN | |
| SECONDARY | Postoperative Pain Scores - Inpatient Floor | up to 48 hours, from arrival to inpatient floor until discharge home | Pain score NSR | MEAN | |
| SECONDARY | Length of Stay in the PACU | up to 24 hours | minutes | MEAN | |
| SECONDARY | Length of Stay on the Inpatient Floor | up to 30 days | days | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit | Sufentanil SL Arm | 3.22 | Standard Deviation 2.42 | Pain score NSR | |
| Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit | IV Remifentanil Historical Arm | 5.66 | Standard Deviation 2.19 | Pain score NSR | |
| Average Postoperative Pain Score - PACU/ Post-anesthesia Care Unit | IV Sufentanil Historical Arm | 5.05 | Standard Deviation 2.38 | Pain score NSR | |
| Opioid Consumption - PACU | Sufentanil SL Arm | 6.13 | Standard Deviation 10.79 | morphine milligram equivalents | |
| Opioid Consumption - PACU | IV Remifentanil Historical Arm | 29.02 | Standard Deviation 21.45 | morphine milligram equivalents | |
| Opioid Consumption - PACU | IV Sufentanil Historical Arm | 23.06 | Standard Deviation 21.61 | morphine milligram equivalents | |
| Opioid Consumption - Inpatient Floor | Sufentanil SL Arm | 41.59 | Standard Deviation 36.43 | morphine milligram equivalents | |
| Opioid Consumption - Inpatient Floor | IV Remifentanil Historical Arm | 74.51 | Standard Deviation 44.17 | morphine milligram equivalents | |
| Opioid Consumption - Inpatient Floor | IV Sufentanil Historical Arm | 74.99 | Standard Deviation 45.71 | morphine milligram equivalents | |
| Postoperative Pain Scores - Inpatient Floor | Sufentanil SL Arm | 3.96 | Standard Deviation 1.61 | Pain score NSR |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sufentanil SL Arm | 39 | |
| Overall Study | STARTED | IV Remifentanil Historical Arm | 80 | |
| Overall Study | STARTED | IV Sufentanil Historical Arm | 80 | |
| Overall Study | COMPLETED | Sufentanil SL Arm | 30 | |
| Overall Study | COMPLETED | IV Remifentanil Historical Arm | 80 | |
| Overall Study | COMPLETED | IV Sufentanil Historical Arm | 80 | |
| Overall Study | NOT COMPLETED | Sufentanil SL Arm | 9 | |
| Overall Study | NOT COMPLETED | IV Remifentanil Historical Arm | 0 | |
| Overall Study | NOT COMPLETED | IV Sufentanil Historical Arm | 0 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Other | Respiratory, thoracic and mediastinal disorders | Sufentanil SL Arm | 3 | 39 | 3 |
| serious | Other | Respiratory, thoracic and mediastinal disorders | IV Remifentanil Historical Arm | 0 | 80 | 0 |
| serious | Other | Respiratory, thoracic and mediastinal disorders | IV Sufentanil Historical Arm | 0 | 80 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sufentanil SL Arm | 0 | 39 |
| Total, all-cause mortality | IV Remifentanil Historical Arm | 0 | 80 |
| Total, all-cause mortality | IV Sufentanil Historical Arm | 0 | 80 |
| Total, other adverse events | Sufentanil SL Arm | 0 | 39 |
| Total, other adverse events | IV Remifentanil Historical Arm | 0 | 80 |
| Total, other adverse events | IV Sufentanil Historical Arm | 0 | 80 |
| Total, serious adverse events | Sufentanil SL Arm | 3 | 39 |
| Total, serious adverse events | IV Remifentanil Historical Arm | 0 | 80 |
| Total, serious adverse events | IV Sufentanil Historical Arm | 0 | 80 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04263909
GET https://conductscience.org/api/trials/v1/NCT04263909/registered