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

Child, Hospitalized Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Child, Hospitalized

• NCT number: NCT04275336
• Study type: Interventional
• Source: Children's Hospital of Fudan University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Completion date: May 12, 2020