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

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

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 Overview

• Status: Completed
• Conditions: Child, Hospitalized
• Intervention / Treatment: Drug: EMLA application; Behavioral: Distraction techniques; Other: EMLA cream and distraction techniques

Detailed Description

Intravenous infusion is a routing practice of drug administration for hospitalized children.However numerous studies have shown that venipuncture is a major source of pain of children during their hospitalization which can lead to moderate to severe pain and cause fear, stress and anxiety in children if there is no effective pain management.

The current pain relieving methods include pharmacological (i.e. topical anesthetic) and non-pharmnacological (i.e. distraction techniques) interventions. pharmacological There are scarce evidences supporting that a combination of pharmacological and non-pharmacological interventions can enhance children's abilities in coping with their pain and stress during the venipuncture. EMLA cream is a main pharmacological intervention in managing needle-related pain which can penetrate the cuticle and epidermal layer of intact skin, enter the dermis where nerve endings are located, and relieve pain. However pharmacological interventions have proven inadequate in mitigating pain and stress.The main non-pharmacological alternatives is distraction techniques. There are extremely limited data studies on merging pharmacological and non-pharmacological interventions to compensate for each other's inadequacies. Hence, this study aimed to evaluate the effect of combining both topical anesthetic and distraction techniques in comparison with either of the interventions applied singly.

This study adopts a randomized, blind, controlled intervention trial. Participants will be randomly assigned to three groups: EMLA group, Distraction group and Combined group (EMLA cream plus distraction techniques). The outcomes will be measured by self-reported pain, parent-reported pain and observer-reported pain. Salivary cortisol level will be measured by the ultra sensitive Cortisol Saliva ELISA Assay Kit. Other physiological metrics like heart rate, SpO2, and other intravenous cannulation factors will be rated and recorded.

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMLA group; 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; 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.; Other Names: EMLA cream
Experimental: Distraction group; 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; 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 Names: Distractions
Experimental: Combined group; 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; 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 Names: EMLA cream and distractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Salivary Cortisol	Physiological stress levels are measured by means of salivary cortisol as an indicator. The salivary samples (1-2 milliliter) are taken with sterile collection devices immediately after children reporting pain score. The salivary samples are immediately stored at -20℃ freezer. Cortisol levels are determined by human salivary cortisol ELISA Kit (Jianglai, Shanghai, China). This si no cut-off score and the higher scores means a worse outcomes	Immediately after children reporting pain score
Heart Rate	Evaluate the physiological response (heart rate) caused by peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Heart rate (beats per minute) is measured and recorded.	During the peripheral intravenous insertion procedure.
Pulse Oximetry Saturation	Evaluate the physiological response (pulse oximetry saturation) secondary to peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Pulse oximetry saturation（percentage）is measured and recorded.	During the peripheral intravenous insertion procedure.
Retaining Time of Intravenous Cannula	Time (hours) from needle insertion to remove.	When the needle is removed.
Venipuncture Duration	record how long is children's first venipuncture duration	During children's first venipuncture

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Chair: Ying Gu, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 16, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Children; EMLA; venipuncture related pain and stress; distraction techniques
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Anesthetics, Combined; Lidocaine, Prilocaine Drug Combination
• Other Study ID Numbers: FNF201829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No