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A Randomized, Double-blind, Placebo-Controlled Trial

Christopher J. Hartnick, MD; Benjamin E. J. Hartley, MD; Peter D. Lacy, MD; James Liu, MD; Judy A. Bean, PhD; J. Paul Willging, MD; Charles M. Myer III, MD; Robin T. Cotton, MD

Arch Otolaryngol Head Neck Surg. 2001;127:1260-1264.

Objective  To explore the effect of mitomycin treatment on the pediatric airway following laryngotracheal reconstruction.

Design  Randomized, double-blind, placebo-controlled trial.

Patients  Children aged 2 to 17 years with subglottic or upper tracheal stenosis undergoing laryngotracheal reconstruction at a single, tertiary care, children's hospital.

Intervention  At the time of extubation or stent removal, the children underwent bronchoscopy and 0.4 mg/mL (2 mL of a 0.2-mg/mL solution of either mitomycin or an equal volume of isotonic sodium chloride was directly applied to the subglottic region for a single application of 2 minutes. These children then underwent interval endoscopy at 2 weeks, 6 weeks, and 3 months postoperatively for assessment of their airways.

Results  Granulation tissue was graded on a scale of 0 (none) to 4 (near-total or total occlusion). Videotapes of endoscopies were independently observed and graded by 3 pediatric otolaryngology fellows with a subsequent interobserver agreement of 91.6%. The results were then dichotomized to represent a single cohort in which further surgical intervention would be required and another separate cohort in which further surgery would not be required. At the 1-year mark, interim analysis was performed by a Data Safety and Monitoring Committee. At this time, 13 children had been randomized to the mitomycin-treated arm of the study and 11 children to the placebo-treated arm. A 2-tailed Fisher exact test revealed a value of 1.00. The Data Monitoring and Safety Committee advised that the trial should be stopped because the distributions between the 2 populations were almost identical.

Conclusion  We cannot reject the null hypothesis that a single topical dose of mitomycin exerts an equal benefit as does isotonic sodium chloride when applied to the pediatric airway after laryngotracheal reconstruction.

From the Departments of Pediatric Otolaryngology (Drs Harnick, Hartley, Lacy, Liu, Willging, Myer, and Cotton) and Biostatistics (Dr Bean), Children's Hospital Medical Center, Cincinnati, Ohio. Dr Hartnick is now with Harvard Medical School, Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston.

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