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Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.

NCT04275336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2023-09-21

Study results available
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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.

Conditions

  • Child, Hospitalized

Interventions

DRUG

EMLA application

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.

BEHAVIORAL

Distraction techniques

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.

OTHER

EMLA cream and distraction techniques

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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Ying Gu · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2020-04-30
Completion
2020-05-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275336 on ClinicalTrials.gov