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THE EFFECT OF ANTIBIOTICS ON POST-ADENOTONSILLECTOMY MORBIDITY IN TANZANIAN CHILDREN

PROPHYLACTIC ROLE OF AMOXICILLIN ON POSTOPERATIVE MORBIDITY AFTER (ADENO)TONSILLECTOMY AMONG CHILDREN IN NORTHERN TANZANIA: A DOUBLE BLIND RANDOMIZED PLACEBO CONTROLLED TRIAL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR201905466349317
Enrollment
270
Registered
2019-05-15
Start date
2019-01-20
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Ear, Nose and Throat Adenotonsillitis Surgery Paediatrics

Interventions

Amoxicillin
Placebo

Sponsors

Training Health Researchers into Vocational Excellence THRiVE
Collaborator
Tanzania Ministry of Health Community Development Gender Elderly and Children MoHCDEC
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All Children from age of 2 and 14 years who will undergo (adeno) tonsillectomy because of recurrent chronic tonsillitis as defined as 5 or more attacks of tonsillitis each year for at least 2 consecutive years or because of obstructive sleep apnea due to adenotonsillar hypertrophy who ave not responded with pharmacotherapy

Exclusion criteria

Exclusion criteria: Reported allergy to penicillin, ibuprofen or Paracetamol. Acute tonsillar infection. Undergoing unilateral tonsillectomy, tonsillar biopsy, tonsillectomy for known carcinoma, tonsillectomy in conjunction with palatal surgery and tonsillectomy for peritonsillar abscess. Heart diseases, prosthetic heart valves or any implant in situ. Received antibiotic(s) for the last seven days. Conditions resulting into weakness or failure of the host defense mechanism due to leukemia, acquired immune deficiency syndrome or immunosuppressive treatments. Syndromic children and children with craniofacial malformations. Patients who are using any concomitant medications at the time of enrolment

Design outcomes

Primary

MeasureTime frame
Postoperative haemorrhage;Postoperative pain;Postoperative fever

Secondary

MeasureTime frame
time until normal diet is resumed;time until normal activities are resumed;adverse events such as a rash, vomiting, diarrhea and anaphylaxis;microbial recolonization of the tonsillar beds

Countries

United Republic of Tanzania

Contacts

Public ContactDenis Robert Katundu

Resident Doctor

katundu101@gmail.com+255713828862

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026