TABLE 4

Narrative Summary of AEs of Treatment Reported by 7 Trials

TrialHS (n) vs Controls (n)Main Findings
Everard 201443% saline (n = 142) vs standard care (n = 143)Six AEs were possibly related to saline treatment, including 1 serious AE (SAE), bradycardia and desaturation, which resolved the following day. The remaining 5 non-SAEs were bradycardia (self-correcting), desaturation, coughing fit, and increased respiratory rate (all of which were resolved within 1 d), and a chest infection that resolved after 6 d.
Grewal 2009133% saline + epinephrine (n = 23) vs 0.9% saline + epinephrine (n = 23)AEs were noted in 4 infants (vomiting, 3; diarrhea, 1); all were enrolled in the HS group. No additional bronchodilators were given to any enrolled patient during the study period.
Kuzik 2007123% saline (n = 47) vs 0.9% saline (n = 49)No infants were withdrawn by the medical staff due to AEs, although 5 infants were withdrawn at parents’ request because of perceived AEs, only 2 from the HS group, of whom 1 presented with vigorous crying and another with agitation.
Li 2014355% saline (n = 40), 3% saline (n = 42) vs 0.9% saline (n = 42)No AEs were observed in the 3% and 0.9% saline groups. Four patients from the 5% saline group presented with paroxysmal cough during saline inhalation.
Luo 2011193% saline (n = 57) vs 0.9% saline (n = 55)No infants were withdrawn by the medical staff because of AEs. Coughing and wheezing never worsened during saline inhalation, although 5 infants had hoarse voices, only 2 from the HS group, and the symptom disappeared after 3–4 d.
Teunissen 2014243%, 6% saline + salbutamol (n = 167) vs 0.9% + salbutamol (n = 80)A substantial number of AEs (eg, cough, bronchospasm, agitation, desaturation) were noted in all treatment groups. Except for cough, which occurred significantly more in the HS groups (P = .03), no differences were found between groups. Withdrawals due to AEs did not differ between groups (4.3%, 6.1% and 7.9% in the 3%, 6% and 0.9% saline groups, respectively, P = .59).
Wu 2014303% saline (n = 211) vs 0.9% saline (n = 197)Three patients in the NS group and 4 in the HS group withdrew owing to parent request. Of these parent requests, 1 in the NS group and 2 in the HS group were attributed to worsening cough. For these 3 patients, pretreatment and posttreatment vital signs and RDAI score were the same or improved, and no intervention or additional treatment was necessary.