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Efficacy of transnasal butorphanol tartrate in postepisiotomy pain: a model to assess analgesia.

Authors
  • Joyce, T H 3rd
  • Kubicek, M F
  • Skjonsby, B S
  • Jones, M M
Type
Published Article
Journal
Clinical Therapeutics
Publisher
Elsevier
Publication Date
Jan 01, 1993
Volume
15
Issue
1
Pages
160–167
Identifiers
PMID: 8458045
Source
Medline
License
Unknown

Abstract

Butorphanol tartrate, a synthetically derived opioid agonist-antagonist analgesic, was tested in a large group of postpartum women (N = 76) to assess the safety and analgesic efficacy of a recently approved transnasal preparation of this drug in the relief of postepisiotomy pain. The safety and efficacy of intravenous and intramuscular administration of butorphanol tartrate has been established over 14 years of clinical use. The new nasal spray dosage form offers a similar degree of efficacy with a rapid onset of action. Compared with the injectables and other drugs in this class, transnasal butorphanol has a longer duration of action (4 to 5 hours). In this double-blind, parallel-group, dose-response study, 76 female patients ages 17 to 37 years with moderate to severe postepisiotomy pain were randomly assigned to receive a single dose of transnasal butorphanol (0.25, 0.5, 1, or 2 mg) or placebo. The patients were evaluated for 6 hours. The results of the study indicate that the 1-mg and 2-mg doses were associated with greater efficacy compared with placebo using several markers for efficacy, including the pain relief score and time to remedication. The drug was well tolerated, dizziness and drowsiness being the most frequently reported adverse effects. Adverse effects appeared to be dose related.

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