Clark 2008.
Methods | Pilot phase II randomised cross‐over double‐blind controlled efficacy study | |
Participants | 21 participants randomised; all admitted within previous 72 hours with expectation that terminal phase (last 48‐72 hours of life) would occur during that admission. 11 of the randomised participants did not receive any medication: died or secretions settled before medications administered. Of remaining 10 (5 randomised to each arm): 3 females, 7 males. Median age: 79 years (range 63‐88 years) All had advanced cancer |
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Interventions | Two arms: (1) Hyoscine hydrobromide 400 mcg subcutaneously, then if required, octreotide 200 mcg subcutaneously; OR (2) Octreotide 200 mcg subcutaneously, then if required, hyoscine hydrobromide 400 mcg subcutaneously. Second injection to be administered at nurse's discretion (if further intervention deemed to be required) any time after one hour following first injection. |
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Outcomes | Questionnaire completed by assessing nurse: intensity of noisy breathing (none, mild, moderate, severe, very severe), level of patient comfort, level of consciousness, general hydration status, state of skin at injection site, incidence of vomiting. Nurse questionnaire completed at time of each injection, and at 30 minutes, 1 hour, 4 hours and 6 hours after each injection. Median time to second injection being required: Hyoscine‐first arm: 3 hours (range 1‐8 hours) Octreotide‐first arm: 3 hours (range 1‐6 hours). After one hour: Hyoscine‐first arm: intensity of noisy breathing unchanged from baseline in 3 out of 5 people (1 out of 5 was worse) Octreotide‐first arm: intensity of noisy breathing unchanged from baseline in 4 out of 5 people |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Through hospital pharmacy's centralised service ‐ computerised sequence generation |
Allocation concealment (selection bias) | Low risk | Through hospital pharmacy's centralised service ‐ blinded medication disbursement |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Incomplete outcome data addressed | Low risk | 11 participants randomised but died or secretions settled before intervention: no possibility of measuring outcomes. |
Blinding | Low risk | Through hospital pharmacy's centralised service ‐ blinded medication disbursement |