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. 2012 Jan 18;2012(1):CD007759. doi: 10.1002/14651858.CD007759.pub3

McDonald 1999

Methods RCT
Participants Emergency department of a tertiary care children’s hospital in the USA. July 1996 to December 1997
Inclusion criteria: younger than 7 years presenting with a complaint of an upper extremity injury and who were refusing to use their arm Exclusion criteria: history of neurologic impairment, congential bony malformation, oedema or obvious bony deformity
148 participants enrolled of whom 13 were excluded: 6 had a fracture; 2 spontaneously reduced; in 2 cases the study protocol was not followed; and in 3 cases data were missing
58 boys and 77 girls
Age range: 3 months to 6 years
Interventions Rapid pronation and flexion versus rapid supination and flexion
Outcomes Success rate (success was defined as using the arm to reach for a toy or piece of candy within 30 minutes after manipulation) after first attempt. If failed, second attempt used same procedure and third attempt used the other procedure.
Pain during manipulation measured by the physician and the parent on an ordinal scale (0 = no pain, 1 = little pain, 2 = quite a lot of pain, 3 = very bad pain)
Parents' scoring sheets were illustrated with descriptive drawings of facial expressions.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Blocked randomisation list generated by computer. Trial was balanced after every 10 patients.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) All outcomes High risk Participants: not possible Treatment provider: not possible Outcome assessor: unclear but probably not
Incomplete outcome data (attrition bias) All outcomes Low risk Low risk for primary outcome. Unclear for pain assessments: three participants missing in pronation group.
Selective reporting (reporting bias) Unclear risk Unsure
Other bias Unclear risk No important baseline imbalance

VAS: visual analogue scale