Lloret 1986.
| Methods | Randomised, double blind, single IV & sublingual dose,
2 hrs No placebo group Baseline PI=moderate or severe pain Self assessment at t=0, 10, 20, 30, 60, 120 min |
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| Participants | N=43 Intravenous dipyrone 2.5 g + pitofenone 10 mg + fenpipramide bromomethylate 0.1mg (Baralgin), n=18 Sublingual nifedipine 10 mg, n=25 |
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| Interventions | Intravenous dipyrone 2.5 g + pitofenone 10 mg + fenpipramide bromomethylate 0.1mg (Baralgin) Sublingual nifedipine 10 mg Remedication was allowed 15 min after the initial dose if a clear improvement was not observed. After another 15 min a third dose was given (treatment regimes were swapped so that a patient who received dipyrone at the start was given nifedipine, and vice versa |
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| Outcomes | PI: standard scale (0‐3) 30 min data provided; up to 15 min uncontaminated single dose data. 15 min SPID: Dipyrone=0.2785 Nifedipine=0.1749 |
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| Notes | AE information is 'number of events' not 'number of patients'. Multiple dose AEs: Number of AEs: nifedipine (1); dipyrone (15) Warm feeling & metalic taste, dry mouth, sweating: dipyrone (7). Nausea: dipyrone (2); nifedipine (1). Dizziness: dipyrone (1) Somnolence: dipyrone (1) Headache: Dipyrone (1) Pain at injection site ‐ dipyrone (3) QS=2 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |