Trial · NCT01744197
Synera Venipuncture Pain
NCT01744197, Phase 2, Completed, US Oncology Research; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Synera Venipuncture Pain. Trials, record NCT01744197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01744197
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Synera Venipuncture Pain
- NCT number
- NCT01744197
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- US Oncology Research
- Conditions
- Pain, Phlebotomy, Palliative Care
- Interventions
- Synera (lidocaine 70mg/tetracaine 70mg)
- First posted
- 2012-12-06
- Last updated
- 2018-10-25
- Results first posted
- 2016-02-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With No or Minor Pain (VAS<3) | 30 minutes after the venipuncture. | The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS \<3 is considered as patients with no or minor pain and would be compared between 2 groups. |
| Primary | Percentage of Patients With No Pain (VAS=0) | 30 minutes after the venipuncture. | The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups. |
| Secondary | Global Assessment of Satisfaction With Venipuncture | 30 minutes after the venipuncture. | Rates of Satisfied and very satisfied are used to be compared between two groups. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With No or Minor Pain (VAS<3) | 30 minutes after the venipuncture. | Normal completion patients. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Patients With No Pain (VAS=0) | 30 minutes after the venipuncture. | Normal completion patients | percentage of participants | NUMBER |
| SECONDARY | Global Assessment of Satisfaction With Venipuncture | 30 minutes after the venipuncture. | Normal completion patients | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With No or Minor Pain (VAS<3) | Synera | 38.0 | percentage of participants | ||
| Percentage of Patients With No or Minor Pain (VAS<3) | Placebo | 21.3 | percentage of participants | ||
| Percentage of Patients With No Pain (VAS=0) | Synera | 19.4 | percentage of participants | ||
| Percentage of Patients With No Pain (VAS=0) | Placebo | 8.3 | percentage of participants | ||
| Global Assessment of Satisfaction With Venipuncture | Synera | 74.0 | percentage of participants | ||
| Global Assessment of Satisfaction With Venipuncture | Placebo | 53.7 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Synera First, Then Placebo | 32 | |
| Overall Study | STARTED | Placebo First, Then Synera | 29 | |
| Overall Study | COMPLETED | Synera First, Then Placebo | 28 | |
| Overall Study | COMPLETED | Placebo First, Then Synera | 26 | |
| Overall Study | NOT COMPLETED | Synera First, Then Placebo | 4 | |
| Overall Study | NOT COMPLETED | Placebo First, Then Synera | 3 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| other | VERY SLIGHT ERYTHEMA | Skin and subcutaneous tissue disorders | Synera | 11 | 54 | 11 |
| other | VERY SLIGHT ERYTHEMA | Skin and subcutaneous tissue disorders | Placebo | 11 | 54 | 11 |
| other | WELL-DEFINED ERYTHEMA | Skin and subcutaneous tissue disorders | Synera | 14 | 54 | 14 |
| other | WELL-DEFINED ERYTHEMA | Skin and subcutaneous tissue disorders | Placebo | 7 | 54 | 7 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Synera | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Synera | 25 | 54 |
| Total, other adverse events | Placebo | 18 | 54 |
| Total, serious adverse events | Synera | 0 | 54 |
| Total, serious adverse events | Placebo | 0 | 54 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Synera vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01744197
GET https://conductscience.org/api/trials/v1/NCT01744197/registered