Godoy 2010.
Methods | RCT Approved by the ethics committee and signed informed consents obtained Setting: Argentina Funding: unspecified |
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Participants | 154 adult participants > 65 years old who presented to the emergency department because of a previously undiagnosed and untreated hip fracture Excluded: anatomical abnormalities in the inguinal area different from fracture, known coagulation disorders, history of allergy to any of the active ingredients used during the study, refusal to participate | |
Interventions |
Treatment group: fascia iliaca compartment block with 0.3 mL/kg 0.25% bupivacaine and 5 mL 5% dextrose (n = 92) Control group: normal saline in the fascia iliaca compartment and IV non‐steroidal anti‐inflammatory drugs (diclofenac or ketorolac) (n = 62) |
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Outcomes | Pain scores at rest at 15 minutes after block placement Confusion |
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Notes | Protocol included observing participants for 8 hours The only complications were local bruises at the site of injection |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomized into 2 groups (A and B) with numbers generated by the EPI‐INFO™ (Atlanta, GA: Centers for Disease Control and Prevention) programme |
Allocation concealment (selection bias) | Low risk | Randomization list was kept by one of the study authors who did not interact with participants. He gave instructions to participants’ ED nurse about which treatment should be administered |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Nurse prepared the medication according to physician’s instructions and assigned a letter to the protocol (from a set of 10 letters: 5 for group A and 5 for group B) that designated whether the participant was receiving active medications in the fascia‐iliaca block. The physician administering medications and obtaining VAS scores did not know which medications the participant was receiving. The treating nurse was aware of the randomization group |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The physician administering the medications and obtaining the VAS scores did not know which medications the participant was receiving |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | In all, 175 participants were randomized upon presentation to the ED. A total of 21 were excluded from participation (1) because they or their legal decision‐maker declined to participate, (2) owing to systemic or laboratory abnormalities that interfered with their participation or (3) because they were subsequently found to have missing data (pain scores not recorded or incomplete vital signs on scheduled measurements) |
Selective reporting (reporting bias) | Low risk | All measurements mentioned in methods section given in results section |
Other bias | Low risk | Groups well balanced |