CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 354 enrolled
Drug / intervention
EMLA application +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04275336
NCT04275336N/ACompleted

Pharmacological and Non-pharmachological Interventions in Management of Peripheral Venipuncture Related Pain: a Randomized Clinical Trial

Children's Hospital of Fudan University·interventional·Posted Feb 19, 2020·Updated Sep 21, 2023

In Brief

A clinical study evaluating EMLA application, Distraction techniques, and 1 other intervention for Child, Hospitalized. Completed, enrolled 354 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 19, 2020
Enrollment StartFeb 1, 2020
Primary CompletionApr 30, 2020
Study CompletionMay 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.4 years ago

Interventions

EMLA applicationdrug

A thick layer of cream (lidocaine and propiocaine 2.5%/2.5%) will be applied on a 1x1 cm2 area of skin on the cannulation site. The transparent dressing will be left in place for 30 minutes, then remove and clean with a sterile cotton swab. Then nurse perform IV cannulation for them.

Distraction techniquesbehavioral

Multiple distractions including toy whistles, cartoon books, a TV showing cartoons, and various electronic products with video games will be provided for the children to choose and play with. They will also be taught breathing exercises (i.e. inhaling through the nose for 3 seconds and exhaling for 5 seconds, while they are counting) if they are willing. A play therapist play with the children for 5 min. prior to and throughout the venipuncture procedure.

EMLA cream and distraction techniquesother

both EMLA cream and distraction techniques will be used. EMLA cream will be applied on the pre-puncture site for 30 minutes as the EMLA group, then 5 minutes before the venipuncture, the play therapist encourage them to choose their favorite toys to play with or to learn breathing exercises. During IV cannulation the play therapist will also continue distracting the child with toys.