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. 2002 Oct 21;2002(4):CD003867. doi: 10.1002/14651858.CD003867

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
Participants N=43
Intravenous dipyrone 2.5 g + pitofenone 10 mg + fenpipramide bromomethylate 0.1mg (Baralgin), n=18
Sublingual nifedipine 10 mg, n=25
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
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
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
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate