Ashraf 2015.
| Methods | Design: Randomised controlled trial of oral premedication with diazepam and diphenhydramine versus no premedication in older people undergoing cardiac catheterisation Date of study: Not reported Power calculation: Yes Frequency of outcomes assessment: 4 hours post‐procedure and 1‐day post‐procedure for inpatients Inclusion criteria: Aged > 70 years; elective cardiac catheterisation Exclusion criteria: MMSE <20; pre‐existing delirium on CAM; allergy to diphenhydramine, diazepam or midazolam |
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| Participants | Number in study: 93 (53% inpatients; demographic data for entire sample) Country: USA Setting: Cardiac catheterisation facility within a single site medical centre Age: Mean age 78 years (SD 4.8) in intervention group; 77 years (SD 3.5) in control group Sex: Males 25 (53%) in intervention; 28 (61%) in control Co‐morbidity: Data reported on rates of hypertension, diabetes, hyperlipidaemia, coronary artery disease, anxiety, depression, delirium, COPD and atrial fibrillation. Imbalance on CAD 34% vs 52% and depression 13% vs 4% Dementia: Baseline MMSE comparable between groups. Excluded if MMSE < 20 |
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| Interventions | Intervention: Oral premedication with diazepam 5 mg and diphenhydramine 25 mg Control: No premedication prior to procedure |
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| Outcomes | 1. Incident delirium using CAM 2. Cognitive function using MMSE (data not fully reported in paper) 3. Length of stay (data not fully reported in paper) |
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| Notes | Funding source: Not reported Declaration of interest: Not reported Delirium excluded at enrolment. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | Method not described |
| Random sequence generation (selection bias) | Unclear risk | Method not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo given to the control group |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | States ‘the catheterization laboratory staff and nursing staff that took care of patients after the procedure and majority of the operators were unaware of the randomisation' |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete reporting of all included participants |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information presented to make judgment |
| Other bias | Low risk | No evidence of other bias |