Clinical trial NCT04275336: Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
Official title: Pharmacological and Non-pharmachological Interventions in Management of Peripheral Venipuncture Related Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Hospitalized
Keywords: Children
venipuncture related pain and stress
EMLA
distraction techniques
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 354
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale
timeFrame: Immediately after completing peripheral venipuncture.
measure: Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
timeFrame: Immediately after completing all participants' interventions.
measure: Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC)
timeFrame: Immediately after completing peripheral venipuncture.
Secondary outcomes:
measure: Concentration of Salivary Cortisol
timeFrame: Immediately after children reporting pain score
measure: Heart Rate
timeFrame: During the peripheral intravenous insertion procedure.
measure: Pulse Oximetry Saturation
timeFrame: During the peripheral intravenous insertion procedure.
measure: Retaining Time of Intravenous Cannula
timeFrame: When the needle is removed.
measure: Venipuncture Duration
timeFrame: During children's first venipuncture
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Gu
role: STUDY_CHAIR
References: