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Randomized control study designed to compare the results and outcomes of topical intranasal steroid spray against surgical adenoidectomy in children with chronic adenoiditis

Comparison of the effect of topical nasal steroid spray and adenoidectomy on chronic adenoiditis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007914
Enrollment
100
Registered
2017-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients with chronic adenoiditis

Interventions

Intervention1: medical treatment: Topical nasal steroid spray( fluticasone furoate). 200mcg of fluticasone furoate in two divided doses daily as one spray each nostril morning and evening for 12 weeks

Sponsors

K F KAMMAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adenoid enlargement grade 2 & 3. 2. Age between 6-15 yrs. 3. Willing for regular follow up 4. Cases of chronic adenoiditis with or without SOM 5. Patient who give consent for either of the group of treatment 6. Immuno-competent 7. Non recurrent cases 8. Patients co-operative for DNE. 9. Patients eligible for either groups of treatment

Exclusion criteria

Exclusion criteria: 1. Acute adenoiditis 2. Enlargement of any other components of waldeyer ring other than adenoids 3. Adenoid obstructing choana completely.(grade 1V) and minimally enlarged adenoid (grade 1) 4. Mentally retarded. 5. Recurrence of adenoid after previous surgery & steroid spray. 6. Symptoms of allergy/ high A E C. 7. Rhinosinusitis with post nasal drip

Design outcomes

Primary

MeasureTime frame
1. Adenoid size and presence as assessed by diagnostic nasal endoscopy (DNE). 2. Improvement of signs and symptoms (mouth breathing, snoring, nasal obstruction -VAS, recurrent cold, epistaxis, hyponasal speech) 3. Recurrence & residual disease after treatment assessed by DNE. Timepoint: Three assessment followups during post intervention period 1.one month 2. three month 3. six month

Secondary

MeasureTime frame
1 .Hearing improvement 2. Other Ear symptoms improvement (Earache-VAS) 3. Disappearance of fluid from middle ear 4. Complications of treatment in any of the groups. 5. Any of the treatment groups requiring rescue medication. Timepoint: Three assessment followups during post intervention period 1.one month 2. three month 3. six month

Countries

India

Contacts

Public ContactVikram Bhat K

KARNATAKA INSTITUTE OF MEDICAL SCIENCES

vikram.ent@gmail.com9448658213

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026