The effect of Co-Amoxiclave on post-adenotonsillectomy pain and bleeding

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014010715496N2

Enrollment

150

Registered

2014-01-29

Start date

2012-02-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Post-adenotonsillectomy pain and bleeding.

Interventions

Intervention 1: In intervention group: oral dosage of 5ml CO-Amoxiclave suspention 457 (Amoxicillin 400 mg + Clavulanic Acid 57 mg/5 ml) every 8 hours in adults, 5ml CO-Amoxiclave suspention 312(Amox

Prevention

Control group: will receive placebo made by the local pharmacy in Dastgheib Hospital for one week after tonsillectomy. .

In intervention group: oral dosage of 5ml CO-Amoxiclave suspention 457 (Amoxicillin 400 mg + Clavulanic Acid 57 mg/5 ml) every 8 hours in adults, 5ml CO-Amoxiclave suspention 312(Amoxicillin 250 mg +

Eligibility

Sex/Gender

All

Age

3 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients who undergo tonsillectomy. Indication of tonsillectomy is three or more severe recurrent attacks of tonsillitis within each two consecutive years. Exclusion criteria: medical condition requiring perioperative antibiotics; antibiotics administered within 1 weak prior to tonsillectomy; history of penicillin allergy; children less than 3 years old.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Post-adenotonsillectomy pain. Timepoint: 0.5, 1, 2, 4, 8, 16, 24 Hours after adenotonsillectomy and then four times a day; before breakfast, lunch, dinner and also before sleep for 7 days after surgery. Method of measurement: Visual Analog Scale (VAS).;Post-adenotonsillectomy hemorrhage. Timepoint: Primary hemorrhage: hemorrhage before 24 hours after operation and secondary hemorrhage: after 24 hours after operation. Method of measurement: Observation by ENT specialist.	—

Measure

Time frame

Post-adenotonsillectomy pain. Timepoint: 0.5, 1, 2, 4, 8, 16, 24 Hours after adenotonsillectomy and then four times a day; before breakfast, lunch, dinner and also before sleep for 7 days after surgery. Method of measurement: Visual Analog Scale (VAS).;Post-adenotonsillectomy hemorrhage. Timepoint: Primary hemorrhage: hemorrhage before 24 hours after operation and secondary hemorrhage: after 24 hours after operation. Method of measurement: Observation by ENT specialist.

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Secondary

Measure	Time frame
Time to return to the normal diet. Timepoint: Seven days after adenotonsillectomy. Method of measurement: Questionnaire that fills by the patients or their parents.;Acetaminophen consumption. Timepoint: Seven days after adenotonsillectomy. Method of measurement: Questionnaire that fills by the patients or their parents.;Fever. Timepoint: Seven days after adenotonsillectomy. Method of measurement: The temperature measured by a nurse at the first 24 hour after surgery and by the educated patients or their parents at 2-7 days after operation that records in the questionnaire.	—

Measure

Time frame

Time to return to the normal diet. Timepoint: Seven days after adenotonsillectomy. Method of measurement: Questionnaire that fills by the patients or their parents.;Acetaminophen consumption. Timepoint: Seven days after adenotonsillectomy. Method of measurement: Questionnaire that fills by the patients or their parents.;Fever. Timepoint: Seven days after adenotonsillectomy. Method of measurement: The temperature measured by a nurse at the first 24 hour after surgery and by the educated patients or their parents at 2-7 days after operation that records in the questionnaire.

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Countries

Iran (Islamic Republic of)

Outcome results

None listed

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