Meiri 2016.

Study characteristics
Methods	RCT. 3 arms.
Participants	Number of children: 20 control, 40 treatment (medical clown) Sex of children: 53 M, 47 F (across all 3 arms) Age range of children: 2 ‐ 10 years Mean age range of children: 5.3 ± 2.5 years (across all 3 arms) Needle procedure: IV cannulation or blood draw Diagnosis of child: none reported Inclusion criteria: 2 ‐ 10 years, required blood sampling/line insertion for clinical reasons Exclusion criteria: acutely ill and unstable, or potentially acutely ill and unstable Setting: emergency department and inpatient ward at pediatric hospital in Israel
Interventions	1. Medical clown: A trained medical clown entertained and distracted the child with funny actions (inflating a comical balloon, humorous noises of animals, playing an accordion, singing funny songs) starting 10 minutes before the procedure and ending when the child left the room after the procedure. 2. Local anesthesia by EMLA (active control group): Local anesthesia was applied on the skin surface of the injection site. After 50 minutes, the procedure was performed in the routine way. 3. Standard clinical method (control group): Standard procedure was practised. The child lay on the bed while the parent was holding and talking to the child. A nurse held the hand of the child as the physician took the blood sample.
Outcomes	Pain measures: Child self‐report: scale of 10 faces (0 ‐ 10) Parent report of child pain: VAS (10 cm) Pediatrician report of child pain: VAS (10 cm) Distress measures: Parent report of child anxiety: VAS (10 cm) Pediatric report of child anxiety: VAS (10 cm) Duration of child crying (minutes) Adverse events: none mentioned
Notes	We did not include the EMLA‐only group in this review. Study dates: study dates not reported Funding: non‐restrictive grant from MAGI foundation. Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "by order of arrival". 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	Unclear risk	Unclear as number of participants per group not clearly reported
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes clearly stated and reported
Other bias	High risk	Potential source of bias related to measurement of outcomes