Fulton 2000.
Methods | Randomised trial, parallel‐group design with 4 comparisons | |
Participants | 130 patients. Femoral sheath removed by medical staff 4 to 6 hours after elective or urgent PCI. Manual compression. Median age 64.8 years. 72% males. 20% had previous experience of sheath removal. | |
Interventions | IV morphine 0.05 mg/kg or IV fentanyl 0.5 µg/kg or SC lignocaine 2% 5 ml (100 mg) or IV saline placebo Rescue analgesia (fentanyl) was made available to all groups |
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Outcomes | Pain score using VAS during sheath removal (10 minutes prior, 1 minute and 20 minutes after) Secondary outcomes: use of rescue analgesia; incidence of haematoma and vascular complications, vasovagal reactions, nausea and vomiting Pain scores from patients given analgesia (SC lignocaine, IV morphine, IV fentanyl) were not significantly different from pain scores in placebo group |
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Notes | Quality score 2/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random allocation stated, sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment method not reported. Efforts to obtain additional information from author were unsuccessful. |
Blinding (performance bias and detection bias) Subcutaneous lignocaine | High risk | No subcutaneous placebo |
Blinding (performance bias and detection bias) Intravenous pain regimens | Low risk | Appropriate blinding of participants, clinicians and assessors for intravenous arms (IV placebo, mixed in pharmacy and diluted to same volume) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | No evidence of selective outcome reporting for primary outcomes. Data were not reported by treatment group for secondary outcomes. This meant that meta‐analysis was not possible but this is unlikely to change the conclusions of the review. |
Other bias | Low risk | Statistical adjustment performed for use of fentanyl as co‐intervention |