Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.
Condition: Child, Hospitalized
Study type: Interventional

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.
    

Intervention name(s): EMLA application; Distraction techniques; EMLA cream and distraction techniques
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): 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.; 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.; 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 intervention name(s): EMLA cream; Distractions; EMLA cream and distractions
Intervention MeSH terms: Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Children; venipuncture related pain and stress; EMLA; distraction techniques