McDonald 1999.
Methods | Randomised trial. | |
Participants | Emergency department of a tertiary care children’s hospital in Louisville, USA.
July 1996 to December 1997. Inclusion criteria: children younger than 7 years presenting with a complaint of an upper extremity injury and with refusal to use their arm. Exclusion criteria: history of neurologic impairment, congenital 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. |
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Interventions | Rapid hyperpronation and flexion (n = 67) versus Rapid supination and flexion (n = 68). If failure (child unable to use his/her arm to reach for a toy or piece of candy within 30 minutes after manipulation) after first attempt, second attempt used same procedure and third attempt used the other procedure. |
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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. |
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Notes | Prior to the start of the study, physicians received a brief in‐service training on performing both reduction techniques. Printed instructions given on enrolment forms. Reductions were performed by students or residents (trainees). | |
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 | No trial registration or protocol available. |
Other bias | Low risk | No important baseline imbalance. Care providers and provision of treatment seemed comparable. |