Trial · NCT00530803
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
NCT00530803, Phase 2, Completed, Montefiore Medical Center; results first posted 2018-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children. Trials, record NCT00530803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00530803
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
- NCT number
- NCT00530803
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Pain, Needle Phobia
- Interventions
- EMLA Cream, Synera Patch
- First posted
- 2007-09-17
- Last updated
- 2018-08-31
- Results first posted
- 2018-08-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | immediately after completion of venipuncture | Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, "no pain," to 5, "the most pain you can have." The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5. |
| Secondary | Parent Rating of Child's Pain Using a 6-point NRS | immediately after venipuncture is completed | The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level. |
| Secondary | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | before venipuncture | The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported. |
| Secondary | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | during needle insertion | The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported. |
| Secondary | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | 5 minutes post venipuncture | The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | immediately after completion of venipuncture | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Parent Rating of Child's Pain Using a 6-point NRS | immediately after venipuncture is completed | Number of parent assessment for each pain level on the 6-point NRS. Each participant had only one parental assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS | before venipuncture | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS | during needle insertion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS | 5 minutes post venipuncture | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | EMLA Cream | Participants with FACES Score = 0 (No pain) | 42 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Synera Patch | Participants with FACES Score = 0 (No pain) | 38 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | EMLA Cream | Participants with FACES Score = 1 | 6 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Synera Patch | Participants with FACES Score = 1 | 8 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | EMLA Cream | Participants with FACES Score = 2 | 2 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Synera Patch | Participants with FACES Score = 2 | 3 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | EMLA Cream | Participants with FACES Score = 3 | 0 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Synera Patch | Participants with FACES Score = 3 | 1 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | EMLA Cream | Participants with FACES Score = 4 | 0 | Participants | |
| Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale. | Synera Patch | Participants with FACES Score = 4 | 0 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EMLA Cream | 50 | |
| Overall Study | STARTED | Synera Patch | 50 | |
| Overall Study | COMPLETED | EMLA Cream | 50 | |
| Overall Study | COMPLETED | Synera Patch | 50 | |
| Overall Study | NOT COMPLETED | EMLA Cream | 0 | |
| Overall Study | NOT COMPLETED | Synera Patch | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Erythema | Skin and subcutaneous tissue disorders | EMLA Cream | 6 | 50 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Synera Patch | 7 | 50 | |
| other | Pruitis | Skin and subcutaneous tissue disorders | EMLA Cream | 1 | 50 | |
| other | Pruitis | Skin and subcutaneous tissue disorders | Synera Patch | 0 | 50 | |
| other | pallor | Skin and subcutaneous tissue disorders | EMLA Cream | 20 | 50 | |
| other | pallor | Skin and subcutaneous tissue disorders | Synera Patch | 3 | 50 | |
| other | Edema | Skin and subcutaneous tissue disorders | EMLA Cream | 0 | 50 | |
| other | Edema | Skin and subcutaneous tissue disorders | Synera Patch | 0 | 50 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EMLA Cream | 0 | 50 |
| Total, all-cause mortality | Synera Patch | 0 | 50 |
| Total, other adverse events | EMLA Cream | 27 | 50 |
| Total, other adverse events | Synera Patch | 10 | 50 |
| Total, serious adverse events | EMLA Cream | 0 | 50 |
| Total, serious adverse events | Synera Patch | 0 | 50 |
Source ClinicalTrials.gov
Papers14
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EMLA Cream vs Synera Patch: deaths from any cause | Trial comparisons |
| EMLA Cream vs Synera Patch: serious adverse events | 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/NCT00530803
GET https://conductscience.org/api/trials/v1/NCT00530803/results?page=2