The effect of sublingual fentanyl pill in the treatment of sudden pain in patients with cancer

Efficacy and safety of Fentanyl Sublingual for treatment of Breakthrough Pain in Patients with Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131124015515N8

Enrollment

100

Registered

2019-08-02

Start date

2019-07-22

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breakthrough Pain in Patients with Cancer. Neoplasm related pain (acute) (chronic)

Interventions

Intervention 1: Intervention group: Fentanyl Sublingual tablet: In our study, the available doses of 100 and 200 µg subcutaneous fentanyl: Faran Chemical Co., Iran. Patients are required to record the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 and above Patients with soft, visceral and bone marrow malignancies, patients with a diagnosis of malignant tumors or malignant tumors At least 1-4 episodes of pain per day Receiving an opioid regimen for the control of pain at a constant and similar dose (oral morphine or opioid similar to 60-1000 mg / day / oral oxycodone 30 mg daily) Having informed consent to participate in the study

Exclusion criteria

Exclusion criteria: History of receiving interatcal opioids Patients with history of mucositis / osteomathitis Grade II and above based on the definition of the terminology of the incidence of complications Having a condition that affects subcutaneous fentanyl tolerance or absorption of buccal mucosa Pregnancy / Breastfeeding Sleep apnea Active metastasis in the brain by increasing intracranial pressure Chronic lung obstruction Renal or liver dysfunction Brady's remarkable arrhythmias have not been diagnosed with heart disease Any sudden increase in unrelated cancer pain Conscious unwillingness to participate in the study

Design outcomes

Primary

Measure	Time frame
Pain intensity. Timepoint: At the onset of the episode before the start of the drug, 15, 30, 45 and 60 minutes after starting treatment. Method of measurement: The severity of pain is measured using a numeric rating scale (NRS-11) (0 = painless, mild 1-3, moderate 6-4, severe 10-7).;Episode of pain. Timepoint: Every time a breakthrogh pain occurs. Method of measurement: Recorded by patients.	—

Secondary

Measure	Time frame
Side effects. Timepoint: After taking each dose of medicine. Method of measurement: Recorded by patient.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Hashemi MD.

Shahid Beheshti University of Medical Sciences

dr.hashemi@sbmu.ac.ir+98 21 2261 2252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 24, 2026