Luthy 2013.

Study characteristics
Methods	RCT. 3 arms.
Participants	Number of children: 27 control, 27 treatment (distraction) Sex of children: 32 M, 36 F (across all 3 arms) Age range of children: 2 ‐ 12.5 years Mean age range of children: 5.2 ± 3.4 years (across all 3 arms) Needle procedure: vaccinations Diagnosis of child: none reported Inclusion criteria: 2 ‐ 12 years, child in need of routine vaccinations, parent must have been present for at least 1 of the child’s previous vaccinations Exclusion criteria: children who were diabetic, had poor extremity circulation, had previous allergic reaction to any topical anesthetic, parents with more than 1 child in need of vaccinations Setting: pediatric office located in the second largest county in Utah, United States
Interventions	1.DVD Distraction: Children watched a movie on a small portable DVD player before, during, and after the vaccination. 2.Vapocoolant Spray: A vapocoolant spray was administered to the child for 3 to 7 seconds immediately before the vaccination. 3.Control: Children received no intervention but were given the vaccination as usual.
Outcomes	Pain measure: Parent report of child pain: Wong Baker FACES Pain Scale Distress measure: Parent report of child anxiety: single‐item scale (0 ‐ 5) Adverse events: none mentioned
Notes	We did not include the vapocoolant spray condition in this review. Study dates: study dates not reported Funding: Brigham Young University College of Nursing Research and Scholarship Council Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "computer randomized" (p. 353)
Allocation concealment (selection bias)	High risk	Use of envelopes without appropriate safeguards stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study participants and personnel were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Other bias	High risk	Multiple potential sources of bias related to study design (e.g. underpowered, unclear if other interventions delivered by parents beforehand, use of restraint)