ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Fentanyl Pectin Nasal Spray Reduced Oral-Cancer Related Pain
Clinical Question In a patient with oral cancer, is fentanyl pectin nasal spray (FPNS) compared to immediate-release morphine sulfate (IRMS) more effective in reducing oral cancer related pain?
Clinical Bottom Line Fentanyl pectin nasal spray is more effective in reducing oral cancer related pain than immediate-release morphine sulfate.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 22055892Fallon/ 2011Oral cancer patients (n=110) experiencing cancer pain 1-4 episodes/ dayRandomized Controlled Trial
Key resultsThere was statistically significant improvement in pain intensity difference (PID) at 15 minutes after dosing of fentanyl pectin nasal spray (FPNS) compared with immediate release morphine sulfate (IRMS) (p<. 05) which had onset of at least 30 minutes. FPNS had an onset of pain intensity improvement in 57.5% of episodes at 5 minutes and 95.7% of the episodes by 30 minutes. Whereas IRMS had no significant effects until 30 minutes post-treatment. More adverse effects (AE) were related to FPNS than IRMS treatment. Eight patients reported fourteen serious AE, but most serious AEs were considered to be unrelated to the study drug.
Evidence Search "Fentanyl"[Mesh] AND ("Administration, Intranasal"[Mesh] OR "Nasal Sprays"[Mesh]) Limits: Randomized Controlled Trial
Comments on
The Evidence
The study was a double blind randomized controlled trial. Oral cancer patients at start were all receiving opioid regimens of > 60 mg/ day oral morphine for cancer-related pain and had 1-4 episodes/ day. 110 patients were enrolled in the study and 79 patients completed the study. 10 episodes were treated (5 with FPNS and 5 with IRMS) for each patient. Compliance was adequate with sufficient follow up. Recall bias was unlikely.
Applicability Fentanyl pectin nasal spray is effective at delivering significant rapid reductions in pain that were greater than the effect of IRMS and was able to provide a longer duration of pain relief in the break through cancer pain episodes.
Specialty/Discipline (Public Health) (Oral Medicine/Pathology/Radiology) (Basic Science)
Keywords Oral cancer, pain, fentanyl pectin nasal spray, break through pain
ID# 2270
Date of submission: 04/19/2012spacer
E-mail kusbel@livemail.uthscsa.edu
Author Marisol Kusbel
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Cara Gonzales, PhD, DDS
Faculty mentor/Co-author e-mail gonzalesc5@uthscsa.edu
Basic Science Rationale
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