Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients

NCT01604187 | Completed Phase 4

• 1 other identifier: Abstral
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy; Pain

Keywords

sublingual fentanyl; pain in coloscopy; The efficacy and safety of fentanyl transmucosal tablet to placebo in patients having colonoscopy.

Outcome Measures

Primary Outcomes (1)

• Efficacy of fentanyl transmucosal tablet to placebo in patients having colonoscopy.

  Anxiety will be measured using NRS (0 = no anxiety, 10=maximal anxiety). Pain will be monitored by using numercal rating scale NRS (0-10), sedation by using NRS (0-10, 0= not sedated at all, 10=no response) . Nurse's and surgeon's satisfaction with the procedure will be evaluated using NRS (0-10). Adverse effects of opioids will be evaluated by patients using NRS (0-10)) for the following items: drowsiness (alert / very drowsy), pleasantness (very unpleasant / very pleasant feeling) and nausea/vomiting (no nausea / very strong nausea). In addition, all other adverse effects will be recorded.

Secondary Outcomes (1)

• The safety of fentanyl transmucosal tablet to placebo in patients having colonoscopy.

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Ten minutes before the procedure fentanyl 100 mikrograms sublingual tablet will be given to the patient.

Drug: Fentanyl

Placebo

PLACEBO COMPARATOR

Ten minutes before the procedure placebo sublingual tablet will be given to the patient.

Drug: Placebo

Interventions

Fentanyl DRUG

Ten minutes before the procedure fentanyl sublingual tablet (Abstral ® 100 µg, ProStrakan) will be given to the patient.

Fentanyl

Placebo DRUG

Ten minutes before the procedure placebo sublingual tablet will be given to the patient.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• Colonoscopy
• Written informed consent from participating subject

You may not qualify if:

• A previous history of intolerance to the study drug or related compounds and additives
• History of alcoholism, drug abuse, psychiatric, psychological or other emotional problems that are likely to invalidate informed consent
• Sleep apnoea
• Chronic obstructive pulmonary disease
• BMI ≥ 35 or weight \< 50 kg
• SpO2 \< 90 %
• Concomitant drug therapy known to cause significant enzyme induction or inhibition of CYP 3A4.
• Pregnancy or nursing.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Klaus T Olkkola, professor

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: April 1, 2012
• Primary Completion: April 22, 2019
• Study Completion: April 30, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

FI (1)