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Analgesic sensitivity of two post-partum pain models
Saul S Bloomfield1, Jeanette Mitchell, Gail Cissell
1Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Cincinnati, OH 45267 U.S.A. Department of Obstetrics and Gynecology, University of Cincinnati, College of Medicine, Cincinnati, OH 45267 U.S.A.
Pain
|November 1, 1986
Summary
Post-partum uterine cramping is an excellent model for testing new non-steroidal anti-inflammatory drugs, while episiotomy pain is suitable for weak narcotic and opioid analgesics. Both models effectively demonstrate assay sensitivity in clinical trials.
Area of Science:
- Pharmacology
- Clinical Trials
- Pain Management
Background:
- Post-partum uterine cramping and episiotomy pain are established clinical models for evaluating analgesic efficacy.
- Assessing the relative assay sensitivity of these models is crucial for optimizing drug development.
Purpose of the Study:
- To determine the assay sensitivity of post-partum uterine cramping and episiotomy pain models.
- To compare their effectiveness in detecting differences among analgesic agents.
Main Methods:
- Review of data from 6 Phase II, randomized, placebo-controlled, double-blind studies.
- Inclusion of hospitalized women with moderate to severe post-partum uterine cramping (332 patients) or episiotomy pain (434 patients).
- Patients rated pain intensity and relief over 6-7 hours using subjective reports.
Main Results:
- Post-partum uterine cramping demonstrated excellent assay sensitivity for peripherally acting analgesics, distinguishing between a new drug and aspirin, and between two doses of the new drug.
- The uterine cramp model showed good discrimination between placebo and active agents (downside sensitivity).
- Episiotomy pain models showed similar upside and downside discrimination for weak centrally acting drugs.
Conclusions:
- Post-partum cramping is an excellent pain model for investigating new non-steroidal anti-inflammatory drugs.
- Episiotomy pain is a suitable model for new weak narcotic and opioid analgesics.