Eland 1981.

Study characteristics
Methods	RCT. 4 arms.
Participants	Number of children: 40 (10 in each group) Sex of children: 20 M, 20 F Age range of children: 4.9 ‐ 5.9 years Mean age range of children: not reported Needle procedure: intramuscular injection Diagnosis of child: none given Inclusion criteria: scheduled for pre‐kindergarten physical examinations Exclusion criteria: none given Setting: private pediatrician’s office in a Midwestern city in the United States with a population of 60,000
Interventions	1. Frigiderm coolant with cognitive information: Children were told by the nurse that they would have something sprayed on their leg that would not hurt, would make their leg feel cool, and would make the shot hurt less than other shots they have had. Children had a skin coolant sprayed on the injection site immediately prior to the injection. 2. Frigiderm coolant with no cognitive information: Children were told by the nurse that they would have something sprayed on their leg. Children had a skin coolant sprayed on the injection site immediately prior to the injection. 3. Control aerosol spray with cognitive information: Children were told by the nurse that they would have something sprayed on their leg that would not hurt, would make their leg feel cool, and would make the shot hurt less than other shots they have had. Children had aerosol air sprayed on their leg immediately prior to the injection. 4. Control aerosol spray with no cognitive information: Children were told by the nurse that they would have something sprayed on their leg. Children had aerosol air sprayed on their leg immediately prior to the injection.
Outcomes	Pain measures: Child self‐report: color scale comprising 8 x 1½ inch color squares placed across the bottom of a white felt board representing different events related to varying levels of pain (0 ‐ 3) post‐procedure Distress measures: Parent verbal report: not anxious, somewhat anxious, very anxious Nurse verbal report: not anxious, somewhat anxious, very anxious Adverse events: none mentioned
Notes	We used a total N of 20 for this study (instead of 40) because we only assessed 2/4 conditions (control aerosol spray with cognitive information versus control aerosol spray with no cognitive information). Study dates: study dates not reported Funding: United States Public Health Service, Predoctoral Fellow, 3 F 31‐NU‐05153‐01 Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomized ‐ 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	Personnel were not blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Unclear if participant blinding, but judged not likely to influence outcome measurement
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	Potential source of bias related to outcome measurement (e.g. modified measure with "limited reliability" p.370 Par 4)