Trial · NCT04356352
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
NCT04356352, Phase 2, Phase 3, Terminated, Wake Forest University Health Sciences; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain. Trials, record NCT04356352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04356352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
- NCT number
- NCT04356352
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Injection Site Irritation, Pain
- Interventions
- Lidocaine, Esmolol, Placebo
- First posted
- 2020-04-22
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Pain Score | following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction | pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable |
| Secondary | Heart Rate | heart rate is measured each minute for the first 10 minutes following induction | heart rate is measured as numbers on a scale with normal 60-100 |
| Secondary | Systolic Blood Pressure | Systolic Blood Pressure is measured each minute for the first 10 minutes following induction | blood pressure measured in mmHg |
| Secondary | Oxygen Saturation Percentage | Oxygen saturation measured each minute for the first 10 minutes following induction | oxygen saturation is measured on a percentage, with normal range \>90% |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Pain Score | following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction | score on a scale | MEAN | |
| SECONDARY | Heart Rate | heart rate is measured each minute for the first 10 minutes following induction | beats per minute | MEAN | |
| SECONDARY | Systolic Blood Pressure | Systolic Blood Pressure is measured each minute for the first 10 minutes following induction | mm Hg (millimeters of mercury) | MEAN | |
| SECONDARY | Oxygen Saturation Percentage | Oxygen saturation measured each minute for the first 10 minutes following induction | percentage | MEAN |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Pain Score | Lidocaine | 0.45 | Standard Deviation 0.66 | score on a scale | |
| Patient Pain Score | Esmolol | 0.5 | Standard Deviation 1.02 | score on a scale | |
| Patient Pain Score | Placebo | 1.83 | Standard Deviation 1.07 | score on a scale | |
| Heart Rate | Lidocaine | Minute 2 | 72.6 | Standard Deviation 12.2 | beats per minute |
| Heart Rate | Esmolol | Minute 2 | 81 | Standard Deviation 14.25 | beats per minute |
| Heart Rate | Placebo | Minute 2 | 82 | Standard Deviation 11.15 | beats per minute |
| Heart Rate | Lidocaine | Minute 3 | 72.4 | Standard Deviation 14.18 | beats per minute |
| Heart Rate | Esmolol | Minute 3 | 82 | Standard Deviation 17.46 | beats per minute |
| Heart Rate | Placebo | Minute 3 | 77.2 | Standard Deviation 11.33 | beats per minute |
| Heart Rate | Lidocaine | Minute 4 | 76.9 | Standard Deviation 13.37 | beats per minute |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lidocaine | 13 | |
| Overall Study | STARTED | Esmolol | 13 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | COMPLETED | Lidocaine | 11 | |
| Overall Study | COMPLETED | Esmolol | 10 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Lidocaine | 2 | |
| Overall Study | NOT COMPLETED | Esmolol | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lidocaine | 0 | 11 |
| Total, all-cause mortality | Esmolol | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Lidocaine | 0 | 11 |
| Total, other adverse events | Esmolol | 0 | 10 |
| Total, other adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Lidocaine | 0 | 11 |
| Total, serious adverse events | Esmolol | 0 | 10 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04356352
GET https://conductscience.org/api/trials/v1/NCT04356352/results?page=2