Fanurik 2000.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 80 control, 80 treatment Sex of children: not reported Age range of children: 2 ‐ 16 years (mean age not reported) Needle procedure: IV insertion Diagnosis of child: none (undergoing elective outpatient gastrointestinal endoscopy) Inclusion criteria: 2 ‐ 16 years old, generally healthy, would have EMLA applied for at least 60 min prior to their IV insertion Exclusion criteria: children with chart‐documented, parent‐reported, or suspected developmental delay or cognitive impairment Setting: pediatric outpatients in the Gastroenterology Division of the Arkansas Children's Hospital, USA
Interventions	1. Age‐appropriate distraction: Depending on child age different distracters were offered by nurse (e.g. bubbles, books, music) 2. Typical intervention control: Parents and children were asked to use whatever coping strategies they would typically do (age‐appropriate book was available in the room with no instruction)
Outcomes	Pain measures: Child self‐report: 100 mm VAS Distress measures: Behavioral distress (post‐procedure): 6‐point numerical scale Child self‐report of anticipatory anxiety: 100 mm VAS Parental prediction of child anxiety: 100 mm VAS Adverse events: none mentioned
Notes	Study dates: study dates not reported Funding: none stated Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Children were assigned to one of four stratified age groups (2‐ 4 years, 5‐8 years, 9‐12 years, 13‐16 years) and then randomized to the treatment or control group ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
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	High risk	Imbalance in numbers for missing data across intervention groups
Selective reporting (reporting bias)	High risk	One or more outcomes of interest are reported incompletely
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists