N/A
N=354
Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
Child, Hospitalized
Bottom Line
View on ClinicalTrials.gov: NCT04275336 ↗Enrolled (actual)
354
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale — 2; 2; 2 score on a scale — p=0.511
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EMLA application (Drug); Distraction techniques (Behavioral); EMLA cream and distraction techniques (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Fudan University
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale |
2; 2; 2 | 0.511 |
| PRIMARY Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) |
0; 0; 0 | 0.072 |
| PRIMARY Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) |
1; 1; 1 | 0.906 |
| SECONDARY Concentration of Salivary Cortisol |
35.47; 32.02; 37.7 | 0.035 sig |
| SECONDARY Heart Rate |
104.02; 102.49; 103.65 | 0.844 |
| SECONDARY Pulse Oximetry Saturation |
98; 98; 99 | 0.438 |
| SECONDARY Retaining Time of Intravenous Cannula |
15; 15; 21 | 0.843 |
| SECONDARY Venipuncture Duration |
83; 83; 85.5 | 0.440 |
Summary
To evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture.
Eligibility Criteria
Inclusion Criteria
Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.
Exclusion Criteria
- Emergency peripheral intravenous puncture.
- Allergic history for lidocaine cream.
- Presence of cognitive impairment, hearing impairment or visual impairment.
- Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness.
- Refuse to participate in the study.
Data sourced from ClinicalTrials.gov (NCT04275336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.