Clinical trial
Pharmacological and Non-pharmachological Interventions in Management of Peripheral Venipuncture Related Pain: a Randomized Clinical Trial
Name
FNF201829
Description
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.
Trial arms
Trial start
2020-02-01
Estimated PCD
2020-04-30
Trial end
2020-05-12
Status
Completed
Treatment
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.
Arms:
EMLA group
Other names:
EMLA cream
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.
Arms:
Distraction group
Other names:
Distractions
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.
Arms:
Combined group
Other names:
EMLA cream and distractions
Size
354
Primary endpoint
Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale
Immediately after completing peripheral venipuncture.
Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
Immediately after completing all participants' interventions.
Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
Immediately after completing peripheral venipuncture.
Eligibility criteria
Inclusion Criteria:
Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.
Exclusion Criteria:
1. Emergency peripheral intravenous puncture.
2. Allergic history for lidocaine cream.
3. Presence of cognitive impairment, hearing impairment or visual impairment.
4. Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness.
5. Refuse to participate in the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 354, 'type': 'ACTUAL'}}
Updated at
2023-09-21
1 organization
1 product
2 indications
Organization
Children's Hospital of Fudan UniversityProduct
EMLAIndication
PediatricIndication
Hospitalized