Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients
Status:
Completed
Trial end date:
2019-04-30
Target enrollment:
Participant gender:
Summary
Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the
patient. The pain associated with the procedure is not caused by the insertion of the scope
but from inflating of the colon in order to do the inspection. It has been shown that
colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients
feel discomfort during the procedure. Factors predicting a painful colonoscopy are
female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy
(Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are
associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia
are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an
opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by
using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not
significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et
al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some
sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure;
drug administration, need for pulse oximetry monitoring and the need for follow-up after the
procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that
low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al.
2009).
Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal
sublingual formulation of fentanyl has been developed to further improve the management of
pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed
under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by
the body through the mucous membrane. After administration of buccal fentanyl maximum plasma
drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl
concentrations versus time following buccal and sublingual administration are very similar
(Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the
tongue at the deepest part. Sublingual administration is an easy and non-invasive method of
pain treatment for the patient coming to colonoscopy done as an office based procedure. Other
advantages compared to invasive methods are improved comfort of patients and no need for
intravenous access because of pain relief. Before, it has been used in the management of
breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and
well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use
of transmucosal tablet for colonoscopy patients is a quite new approach.