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

NCT04275336 | Completed Results DMC

• 1 other identifier: FNF201829
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Children; venipuncture related pain and stress; EMLA; distraction techniques

Outcome Measures

Primary Outcomes (3)

• Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale

  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).

  Immediately after completing peripheral venipuncture.

• Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)

  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.

  Immediately after completing all participants' interventions.

• Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)

  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

  Immediately after completing peripheral venipuncture.

Secondary Outcomes (5)

• Concentration of Salivary Cortisol

  Immediately after children reporting pain score

• Heart Rate

  During the peripheral intravenous insertion procedure.

• Pulse Oximetry Saturation

  During the peripheral intravenous insertion procedure.

• Retaining Time of Intravenous Cannula

  When the needle is removed.

• Venipuncture Duration

  During children's first venipuncture

Study Arms (3)

EMLA group

EXPERIMENTAL

The specialist nurse who is to perform IV cannulation determine the puncture site. 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 performed IV cannulation for them.

Drug: EMLA application

Distraction group

EXPERIMENTAL

The 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 are also 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.

Behavioral: Distraction techniques

Combined group

EXPERIMENTAL

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.

Other: EMLA cream and distraction techniques

Interventions

EMLA application DRUG

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.

Also known as: EMLA cream

EMLA group

Distraction techniques BEHAVIORAL

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.

Also known as: Distractions

Distraction group

EMLA cream and distraction techniques OTHER

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.

Also known as: EMLA cream and distractions

Combined group

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.

  PMID: 36737707 DERIVED

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Ms.Yu Zhuowen
• Organization: Children's Hospital of Fudan University

yzw100@126.com

18017591126

Study Officials

• Ying Gu

  Children's Hospital of Fudan University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 19, 2020
• Study Start: February 1, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 12, 2020
• Last Updated: September 21, 2023
• Results First Posted: October 6, 2021

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)