Trial · NCT04275336
Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
NCT04275336, Not applicable, Completed, Children's Hospital of Fudan University; results first posted 2021-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain. Trials, record NCT04275336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04275336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
- NCT number
- NCT04275336
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 354 participants, actual
- Lead sponsor
- Children's Hospital of Fudan University
- Conditions
- Child, Hospitalized
- Interventions
- EMLA application, Distraction techniques, EMLA cream and distraction techniques
- First posted
- 2020-02-19
- Last updated
- 2023-09-21
- Results first posted
- 2021-10-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | Immediately after completing peripheral venipuncture. | Pain outcomes are assessed by child himself or herself using Wong-Baker Faces Pain Rating Scale. The scale includes 6 facial expressions with correlating numbers of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot), 10(hurts worst). Children pick a facial expression, that corresponds with their pain and see a number that matches it. The minimum value is 0 and the maximum value is 10, the higher score means a worse outcome (children having higher level of pain). |
| Primary | Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Immediately after completing all participants' interventions. | The effectiveness is analyzed by outcomes assessors using r-FLACC via video taken during the procedure. The outcomes assessor is blind for the study design. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.the higher scores mean a worse outcome. |
| Primary | Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Immediately after completing peripheral venipuncture. | Pain outcomes are assessed by parents using the r-FLACC scale. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. The higher scores means a worse outcome |
| Secondary | Concentration of Salivary Cortisol | Immediately after children reporting pain score | Physiological stress levels are measured by means of salivary cortisol as an indicator. The salivary samples (1-2 milliliter) are taken with sterile collection devices immediately after children reporting pain score. The salivary samples are immediately stored at -20℃ freezer. Cortisol levels are determined by human salivary cortisol ELISA Kit (Jianglai, Shanghai, China). This si no cut-off score and the higher scores means a worse outcomes |
| Secondary | Heart Rate | During the peripheral intravenous insertion procedure. | Evaluate the physiological response (heart rate) caused by peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Heart rate (beats per minute) is measured and recorded. |
| Secondary | Pulse Oximetry Saturation | During the peripheral intravenous insertion procedure. | Evaluate the physiological response (pulse oximetry saturation) secondary to peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Pulse oximetry saturation（percentage）is measured and recorded. |
| Secondary | Retaining Time of Intravenous Cannula | When the needle is removed. | Time (hours) from needle insertion to remove. |
| Secondary | Venipuncture Duration | During children's first venipuncture | record how long is children's first venipuncture duration |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | Immediately after completing peripheral venipuncture. | score on a scale | MEDIAN | |
| PRIMARY | Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Immediately after completing all participants' interventions. | score on a scale | MEDIAN | |
| PRIMARY | Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Immediately after completing peripheral venipuncture. | score on a scale | MEDIAN | |
| SECONDARY | Concentration of Salivary Cortisol | Immediately after children reporting pain score | percentage of salivary cortisol | MEDIAN | |
| SECONDARY | Heart Rate | During the peripheral intravenous insertion procedure. | beat per minute | MEAN | |
| SECONDARY | Pulse Oximetry Saturation | During the peripheral intravenous insertion procedure. | percent of oxyhemoglobin | MEDIAN | |
| SECONDARY | Retaining Time of Intravenous Cannula | When the needle is removed. | hours | MEDIAN | |
| SECONDARY | Venipuncture Duration | During children's first venipuncture | seconds | MEDIAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | EMLA Group | 2 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | Distraction Group | 2 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale | Combined Group | 2 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | EMLA Group | 0 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Distraction Group | 0 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Combined Group | 0 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | EMLA Group | 1 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Distraction Group | 1 | Inter-Quartile Range 0.25 to 2 | score on a scale | |
| Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) | Combined Group | 1 | Inter-Quartile Range 0 to 2 | score on a scale | |
| Concentration of Salivary Cortisol | EMLA Group | 35.47 | Inter-Quartile Range 27.05 to 43.225 | percentage of salivary cortisol |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EMLA Group | 120 | |
| Overall Study | STARTED | Distraction Group | 118 | |
| Overall Study | STARTED | Combined Group | 116 | |
| Overall Study | COMPLETED | EMLA Group | 103 | |
| Overall Study | COMPLETED | Distraction Group | 96 | |
| Overall Study | COMPLETED | Combined Group | 100 | |
| Overall Study | NOT COMPLETED | EMLA Group | 17 | |
| Overall Study | NOT COMPLETED | Distraction Group | 22 | |
| Overall Study | NOT COMPLETED | Combined Group | 16 |
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 | EMLA Group | 0 | 103 |
| Total, all-cause mortality | Distraction Group | 0 | 96 |
| Total, all-cause mortality | Combined Group | 0 | 100 |
| Total, other adverse events | EMLA Group | 0 | 103 |
| Total, other adverse events | Distraction Group | 0 | 96 |
| Total, other adverse events | Combined Group | 0 | 100 |
| Total, serious adverse events | EMLA Group | 0 | 103 |
| Total, serious adverse events | Distraction Group | 0 | 96 |
| Total, serious adverse events | Combined Group | 0 | 100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36737707 | DERIVED |
Source PubMed
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/NCT04275336
GET https://conductscience.org/api/trials/v1/NCT04275336/results?page=2