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The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies.
Anesth Analg. 2007 Nov; 105(5):1428-36, table of contents.A&A

Abstract

BACKGROUND

Postoperative pain is often managed using IV patient-controlled analgesia (PCA). In this analysis of pooled data, we compared the safety and efficacy of the fentanyl iontophoretic transdermal system (ITS) with morphine IV PCA.

METHODS

Data were obtained from three multicenter, randomized, active-controlled trials (N = 1941). The primary efficacy measure was success ("good"/"excellent" ratings) on the 24-h patient global assessment of the method of pain control. Pain intensity, relative dosing ratios, discontinuation rates, and adverse events were assessed. Efficacy was evaluated across age, surgery type, and body mass index (BMI).

RESULTS

Comparable percentages of patients reported success on the 24-h patient global assessment of the method of pain control (fentanyl ITS, 80.5%; morphine IV PCA, 81.0%; difference = -0.5%; 95% confidence interval, -4.0% to 3.0%). Mean last pain intensity scores in the first 24 h were comparable (fentanyl ITS, 3.1; morphine IV PCA, 3.0; difference = 0.07; 95% confidence interval, -0.14 to 0.29). Relative dosing ratios of fentanyl to morphine overall and in subpopulations (age, BMI) were comparable over 6, 12, and 24 h. Fentanyl ITS was equally effective when compared with morphine IV PCA for patient subpopulations (age, surgery type, and BMI). Discontinuation rates and the incidence of adverse events were similar between groups.

CONCLUSIONS

These pooled data represent one of the largest head-to-head comparisons of fentanyl versus morphine in a postoperative acute pain setting. Results suggest that fentanyl ITS is effective across subpopulations defined by age and BMI, and support a consistent safety and efficacy profile of fentanyl delivered by fentanyl ITS for postoperative pain management.

Authors+Show Affiliations

Department of Anesthesiology, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA. eugene.viscusi@jefferson.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis

Language

eng

PubMed ID

17959978

Citation

Viscusi, Eugene R., et al. "The Safety and Efficacy of Fentanyl Iontophoretic Transdermal System Compared With Morphine Intravenous Patient-controlled Analgesia for Postoperative Pain Management: an Analysis of Pooled Data From Three Randomized, Active-controlled Clinical Studies." Anesthesia and Analgesia, vol. 105, no. 5, 2007, 1428-36, table of contents.
Viscusi ER, Siccardi M, Damaraju CV, et al. The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies. Anesth Analg. 2007;105(5):1428-36, table of contents.
Viscusi, E. R., Siccardi, M., Damaraju, C. V., Hewitt, D. J., & Kershaw, P. (2007). The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies. Anesthesia and Analgesia, 105(5), 1428-36, table of contents.
Viscusi ER, et al. The Safety and Efficacy of Fentanyl Iontophoretic Transdermal System Compared With Morphine Intravenous Patient-controlled Analgesia for Postoperative Pain Management: an Analysis of Pooled Data From Three Randomized, Active-controlled Clinical Studies. Anesth Analg. 2007;105(5):1428-36, table of contents. PubMed PMID: 17959978.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies. AU - Viscusi,Eugene R, AU - Siccardi,Matthew, AU - Damaraju,C V, AU - Hewitt,David J, AU - Kershaw,Paul, PY - 2007/10/26/pubmed PY - 2007/12/6/medline PY - 2007/10/26/entrez SP - 1428-36, table of contents JF - Anesthesia and analgesia JO - Anesth Analg VL - 105 IS - 5 N2 - BACKGROUND: Postoperative pain is often managed using IV patient-controlled analgesia (PCA). In this analysis of pooled data, we compared the safety and efficacy of the fentanyl iontophoretic transdermal system (ITS) with morphine IV PCA. METHODS: Data were obtained from three multicenter, randomized, active-controlled trials (N = 1941). The primary efficacy measure was success ("good"/"excellent" ratings) on the 24-h patient global assessment of the method of pain control. Pain intensity, relative dosing ratios, discontinuation rates, and adverse events were assessed. Efficacy was evaluated across age, surgery type, and body mass index (BMI). RESULTS: Comparable percentages of patients reported success on the 24-h patient global assessment of the method of pain control (fentanyl ITS, 80.5%; morphine IV PCA, 81.0%; difference = -0.5%; 95% confidence interval, -4.0% to 3.0%). Mean last pain intensity scores in the first 24 h were comparable (fentanyl ITS, 3.1; morphine IV PCA, 3.0; difference = 0.07; 95% confidence interval, -0.14 to 0.29). Relative dosing ratios of fentanyl to morphine overall and in subpopulations (age, BMI) were comparable over 6, 12, and 24 h. Fentanyl ITS was equally effective when compared with morphine IV PCA for patient subpopulations (age, surgery type, and BMI). Discontinuation rates and the incidence of adverse events were similar between groups. CONCLUSIONS: These pooled data represent one of the largest head-to-head comparisons of fentanyl versus morphine in a postoperative acute pain setting. Results suggest that fentanyl ITS is effective across subpopulations defined by age and BMI, and support a consistent safety and efficacy profile of fentanyl delivered by fentanyl ITS for postoperative pain management. SN - 1526-7598 UR - https://www.unboundmedicine.com/medline/citation/17959978/The_safety_and_efficacy_of_fentanyl_iontophoretic_transdermal_system_compared_with_morphine_intravenous_patient_controlled_analgesia_for_postoperative_pain_management:_an_analysis_of_pooled_data_from_three_randomized_active_controlled_clinical_studies_ L2 - https://doi.org/10.1213/01.ane.0000281913.28623.fd DB - PRIME DP - Unbound Medicine ER -