Trial Information
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Inclusion Criteria:
- 1. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory
Papilloma
- 2. Child under age 10
- 3. Informed consent and where appropriate informed assent
- 4. Children who have undergone at least 4 documented surgical interventions in the
past year.
Exclusion Criteria:
- Parental or child refusal to participate
- Heart failure
- Atrio-ventricular heart block
- Cardiac anomalies
- Low resting heart rate
- Low resting blood pressure
- Wolff-Parkinson White Syndrome
- Unexplained syncope
- Asthma or Reactive airway disease
- Renal or liver failure
- Expected long fasting periods, >12 hours
- Diabetes Mellitus
- Hypersensitivity to propranolol
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Decreased number of surgeries
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Christopher Hartnick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts Eye and Ear Infirmary
Authority:
United States: Institutional Review Board
Study ID:
09-10-104
NCT ID:
NCT01058317
Start Date:
January 2010
Completion Date:
September 2010
Related Keywords:
- Recurrent Respiratory Papillomatosis
- respiratory, papilloma, pediatric, juvenile
- Papilloma
- Respiratory Tract Infections
- Papillomavirus Infections