None listed
Conditions
Brief summary
Children diagnosed with mild obstructive sleep apnoea are enrolled and randomised to one of three treatment groups: 1) NS = with nasal steroids alone, 2) NS+AL = nasal steroids plus a leukotriene receptor antagonist, or 3) AD = to surgery with adenoidectomy alone. The aim was to determine whether treatment with surgery (adenoidectomy) or treatment with nasal steroids plus a leukotriene receptor antagonist has clear benefit compared to treatment with nasal steroids alone.. As steroids are routinely used as the first treatment in this disease, outcomes from the surgical and combined treatment (nasal steroid plus leukotriene receptor antagonist) groups will be compared against the group using nasal steroids alone (the comparison group).
Interventions
(NS+LA) nasal steroid (mometasone)
I spray to each nostril daily administered by the parent
combined with a
leukotriene receptor antagonist (Singulair (4 or 5 mg) according to age).
One tablet per day, taken orally
Medications were provided by a trials pharmacist, including monitoring of returns..
Medication was provided without cost to all participants..
Treatment was used for 9.1 ± 2.2 months.
(AD) surgical adenoidectomy without tonsillectomy undertaken by a paediatric ear, nose and thr
(NS+LA) nasal steroid (mometasone) I spray to each nostril daily administered by the parent combined with a leukotriene receptor antagonist (Singulair (4 or 5 mg) according to age). One tablet per day, taken orally Medications were provided by a trials pharmacist, including monitoring of returns.. Medication was provided without cost to all participants.. Treatment was used for 9.1 ± 2.2 months. (AD) surgical adenoidectomy without tonsillectomy undertaken by a paediatric ear, nose and throat surgeon. The procedure use was nasendoscopy and adenoidectomy by curettage and/or suction diathermy. The procedure takes approximately 30 minutes. Adenoidectomy was undertaken as a day-stay procedure under general anaesthetic in all cases. All procedures were undertaken under the guidance of one of the investigators. Surgery was undertaken 5.4 ± 4.7 months after the diagnostic study Follow-up studies were 6.1 ± 1.3 months after the surgery was undertaken
Sponsors
Prof. Karen Waters
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
Patients referred to either the sleep or ENT (ear, nose and throat) outpatient or inpatient services at a tertiary Children’s Hospital (CHW) were invited to participate in the study.
Exclusion criteria
Children who had previously undergone adenotonsillectomy or airway surgery, who had high-risk genetic and craniofacial syndromes or neurodevelopmental conditions, and children with conditions that precluded adenoidectomy
Outcome results
None listed