Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Evaluate the Effectiveness of Vibration and External Cold (Buzzy Device) for Pain Relief During Venipuncture or Intravenous Cannulation in Children With Intellectual Disability.
Brief Summary: Needle procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. Now it's possible to measure pain in children with intellectual disability with specific pain scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).

The efficacy of a device combining vibration and cold for pain relief during venipuncture or IV cannulation has been recently reported in children. The device's actions are based on the Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. To date, there is no study that validated Buzzy device for pain relief in children with intellectual disability.

The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or IV cannulation, in children with intellectual disability.


Options:
A: Inclusion Criteria:

* Children, ages 4-6 years, scheduled to receive the standard pre-kindergarten immunizations. This consists of two injections: the Dtap (diphtheria, tetanus, acellular pertussis) and IPV (injectable polio vaccine) or three injections: DTAP, IPV and MMR (measles, mumps, rubella);
* With or without prior exposure to ST at PMG;
* English speaking subject and parents

Exclusion Criteria:

* Acute concurrent illness;
* Invasive procedures such as cannulation, venipuncture or urinary VCG in the preceding 6 months;
* Hospitalization or ED visit, within the prior 6 months;
* Chronic medical conditions requiring repeated painful interventions;
* Inability to respond age appropriately with verbal and written answers to questions, to pain scale measures, or to questionnaires;
* Refusal to be videotaped.
B: Inclusion Criteria:

* ASA physical status I, II and III a
* age between 4 and 8 years
* undergoing minor-medium elective surgical procedures
* indication of general anesthesia
* not receive premedication
* parents are not illiterate.

Exclusion Criteria:

* psychomotor deficits
* use of psychoactive drugs
* hearing and visual impairment
* previous surgery
* for relatives, illness or mental disorder clinically recognized and decline to participate.
C: Inclusion Criteria:

* ages 5-9 years,
* boys and girls

Exclusion Criteria:

* children with pervasive developmental disability
D: Inclusion Criteria:

* Age 4 to 17 years
* Presence of intellectual disability
* Need of peripheral IV line or venipuncture
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Presence of abrasion, infection or break in skin in the area of Buzzy® placement
* Cold hypersensibility

Answer: D