Pain Relief
Conditions
Keywords
Procedural pain, Phlebotomy, Distraction, Hand-held computer, Children
Brief summary
Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents. In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques. Hand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children. The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture.
Interventions
DEVICEBuzzy® device
DEVICEHand-held computer
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* children from 4 to 12 years of age needing venipuncture
Exclusion criteria
* the presence of damage, denuded or broken skin in the site of Buzzy application; * use of topical, enteral or parenteral analgesics within eight hours before enrolment; * the presence of cognitive impairment or the inability to report pain verbally; * the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported pain | Within 5 minutes after the procedure | Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluated by parents | Within 5 minutes after the procedure | Pain evaluated using a Numerical Rating Scale, with scores from zero to 10 |
| Pain evaluated by nurses | Within 5 minutes after the procedure | Pain evaluated using a Numerical Rating Scale, with scores from zero to 10 |
| Success at first attempt | Intraprocedural | Percentage of success at first attempt |
| Adverse events | Up to 15 minutes after the procedure | The number and the type of adverse events |
Outcome results
None listed