Summary
A new sequential test has been used to compare the effect of paracetamol and placebo on uterine cramping. Paracetamol was significantly superior to placebo at the 5% level. 75 patients were included in the trial, whereas in a fixed sample study 90 patients would have been required to obtain the same significance level and power.
The magnitude of the difference in treatment effect was estimated following the sequential test. In addition to the effect on uterine pain, which was the primary variable, the effect on episiotomy pain was also estimated. Paracetamol was also superior to placebo against the episiotomy pain.
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Bloomfield SS, Barden TP, Mitchell J (1981) comparison of pirprofen, aspirin, acetaminophen, and placebo in postpartum uterine cramp pain. Curr Ther Res 30: S139-S145
Janbu T, Løkken P, Nesheim B-I (1978) Effect of acetylsalicylic acid, paracetamol, and placebo on pain and blood loss in dysmenorrhoeic women. Eur J Clin Pharmacol 14: 413–416
Hopkinson JH, Smith MT, Bare WW, Levin HM, Potsako RJ (1974) Acetaminophen (500 mg) versus acetaminophen (325 mg) for the relief of pain in episiotomy patients. Curr Ther Res 16: 194–200
Hopkinson JH, Bartlett FH, Steffens AO, McGlumphy TH, Macht EL, Smith M (1973) Acetaminophen versus propoxyphene hydrochloride for relief of pain in episiotomy patients. J Clin Pharmacol 13: 251–263
Huskisson EC (1974) Measurement of pain. Lancet II: 1127–1131
Lasagna L, Davis M, Pearson JW (1967) A comparison of acetophenetidin and acetaminophen. I. Analgesic effects in postpartum patients. J Pharmacol Exp Ther 155: 296–300
Lehmann EL (1975) Nonparametrics: Statistical methods based on ranks. Holden-Day, San Francisco
Levin HM, Bare WW, Berry FN, Miller JM (1974) Acetaminophen with codeine for the relief of severe pain in postpartum patients. Curr Ther Res 16: 921–927
Skovlund E, Walløe L (1988) A sequential two-sample test developed by stochastic stimulation. J Stat Comput Simul 29: 87–104
Skovlund E, Walløe L (1989) Estimation of treatment difference following a sequential clinical trial. J Am Stat Assoc 84: 823–828
Skovlund E (1991) Truncation of a two sample sequential Wilcoxon test. Biometr J 33:no. 3
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Skovlund, E., Fyllingen, G., Landre, H. et al. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol 40, 343–347 (1991). https://doi.org/10.1007/BF00265841
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DOI: https://doi.org/10.1007/BF00265841