This was a double randomized prospective study of 49 children age 18
months to 12 years of age using codeine, dextromethorphan, and a placebo
over three nights.1 Parents filled out an intake
questionnaire prior to admission into the study and then every morning
for 3 days. The parents subjectively rated the amount of coughing,
loss of sleep secondary to coughing, and post-tussive emesis.
Inclusion criteria - winter months from 1988-1991 in private pediatricians
offices with c/o night-time cough. To be eligible, patients need
be 18 mo to 12 yrs of age, having a significant cough of <14 days.
A patient must have had parental rating of cough as "often-one
prolonged coughing episode or about 10-20 coughs during the night or
both or "very often-more than one prolonged coughing episode during
the night or more than 20 coughs at night."
Exclusion criteria- they had an underlying lung disease (asthma, CF,
BPD), the cause of their cough was reactive airway disease, or if other
medications such as antibiotics or bronchodilators were needed during
Outcome- parental responses were transformed into a scale: cough score
(0= none and 4= very often), loss of sleep score, and post-tussive emesis
score. Results of scores were compared by using Mann-Whitney tests.
Overall reduction in cough score was evaluated with generalized estimation
equation techniques. For all analyses, differences were considered
significant when the p value was <0.05.
Results- 49 patients (4.7 mean-age) enrolled with 13 receiving placebo,
19 dextromethorphan (DM), and 17 codeine. Cough and Composite
scores improved in each group on each day of the study with no significant
difference between placebo, DM, or codeine groupings. Neither
codeine nor DM was significantly better than placebo (p=0.70 and p=0.41
respectively). Reduction in cough was related to severity of cough
at initiation of therapy (p=0.007).