Petruson 1974.
Methods | Allocation: double‐blind, parallel‐group, placebo‐controlled randomised trial with 10 days of treatment and 10 days of follow‐up | |
Participants |
Setting: inpatients, Sweden Sample size: 68
Participant (baseline) characteristics:
Inclusion criteria: all hospitalised patients with epistaxis Exclusion criteria: none mentioned |
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Interventions |
Intervention group: Cyklokapron (tranexamic acid) 1 g, 3 times daily, started 1 hour after hospitalisation, for 10 days Comparator group: placebo 1 tablet, 3 times daily, started 1 hour after hospitalisation, for 10 days Use of additional interventions: all but 3 of the participants were treated with anterior and/or posterior nasal packing at presentation |
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Outcomes |
Outcomes of interest in the review Primary outcomes
Secondary outcomes
Other outcomes reported by the study
The authors felt that measurement of blood loss was not possible due to the patients swallowing a considerable volume. At the end of the 10‐day study period the participants were brought back to the hospital and questioned about whether any further bleeding had occurred after discharge. |
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Declarations of interest | None stated | |
Funding | None declared | |
Notes | Participants lost to follow‐up: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Assignment ... by random numbers" Comment: this was probably done |
Allocation concealment (selection bias) | Unclear risk | Comment: no information was provided about allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double blind", "The labels of the bottles bore only the patients' serial number" Comment: this was probably done. The bottles did not reveal whether they contained the treatment or placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Double blind" Comment: this was probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "One to three days after the drug treatment was finished the patients visited the hospital again" Comment: it is not stated whether all patients returned or not |
Selective reporting (reporting bias) | Unclear risk | A standard bleeding score was used for all patients Hospitalisation time was recorded from patient records Adherence to these protocols would prevent selective reporting Number of units required for blood transfusion was not recorded |
Other bias | Unclear risk | Quote: "The tampons must be regarded as errors in the evaluation of the therapy effect. When the tampons were taken away or moved small bleeding sometimes started. These small bleedings were not recorded." Comment: this will have had an unknown effect on the overall outcome |