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Evaluation of nebulized N-acetyl cysteine in outcome of esophageal atresia with tracheoesophegeal fistula.

  • 2020-12
  • Journal of pediatric surgery 55(12)
    • Gurmeet Singh
    • Anand Pandey
    • Gaurav Shandilya
    • Archika Gupta
    • J D Rawat
    • Ashish Wakhlu
    • S N Kureel

Study Design

Type
Clinical Trial
Sample size
n = 30
Population
60 patients of esophageal atresia with tracheoesophageal fistula (EA+TEF)
Methods
Non-randomized interventional study; 2 mL of 10% NAC nebulized (2:5 dilution, every six hourly) plus regular suction of upper esophageal pouch vs saline nebulization
Blinding
Open-label
Funding
Unclear

Aim

To evaluate the role of nebulized N-acetyl cysteine (NAC) in liquefying the airway secretions and improving the outcome of patients of esophageal atresia with tracheoesophageal fistula (EA + TEF).

Methods

It was a non-randomized interventional study. Two milliliters of 10% NAC was given in a nebulized form (2:5 dilution, every six hourly) to patients of ET + TEF, along with regular suction of upper esophageal pouch. The group was compared with control, which comprised patients of EA + TEF receiving only saline nebulization. The consistency of the secretions was compared by hand held consistometer in unit of time (seconds) required to cross a predetermined distance along with gravity.

Results

Sixty patients were assessed. Of these, 30 patients were present in both groups. The study group showed significant (p = 0.01-0.0001) decrease in consistency of secretions from the control group after day 2 of NAC nebulization. Patients' discharge was significantly (p = 0.01) earlier in cases. There was no significant (p = 0.41) difference in mortality between the groups. No specific adverse effects were observed in the study group.

Conclusion

It appears that nebulized NAC decreases the consistency of secretions in EA + TEF patients. It is interesting to note that the group of patients that received NAC was discharged earlier than the control group and had a higher survival rate than the control group. Whether this is directly attributable to the use of NAC is unknown. A prospective double-blinded randomized clinical trial is warranted to confirm these results.

Level of evidence

Level II, prospective comparative study (non-randomized).

Research Insights

  • N-Acetyl Cysteine→Reduced Length of Hospital Stay

    Patients' discharge was significantly (p = 0.01) earlier in cases.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    2 mL of 10% NAC, nebulized (2:5 dilution, every six hourly)
  • N-Acetyl Cysteine→Reduced Mortality Risk

    There was no significant (p = 0.41) difference in mortality between the groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    2 mL of 10% NAC, nebulized (2:5 dilution, every six hourly)
  • N-Acetyl Cysteine→Reduced Secretion Consistency

    The study group showed significant (p = 0.01-0.0001) decrease in consistency of secretions from the control group after day 2 of NAC nebulization.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    2 mL of 10% NAC, nebulized (2:5 dilution, every six hourly)

Adverse Events Reported

  • N-Acetyl Cysteine→Overall tolerability

    No specific adverse effects were observed in the study group.

    Finding
    Reported
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