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Comparison of the effect of Acetaminophen and Ibuprofen in pain relief following Adenotonsillectomy.

Comparison of the effect of Acetaminophen and Ibuprofen in pain relief and complication management following Adenotonsillectomy in 4-10 year old children.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013071814047N1
Enrollment
50
Registered
2013-11-07
Start date
2013-06-22
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

Adenotonsillectomy. Enlargement of tonsils, Enlargement of adenoids

Interventions

Intervention 1: Intervention group 1: Syrup Ibuprofen 10mg/ kg orally, once an hour before surgery and then every 6 hour for 3 days was used. This syrup manufacturing company is Hakim co. in Iran and
Treatment - Drugs
Intervention group 1: Syrup Ibuprofen 10mg/ kg orally, once an hour before surgery and then every 6 hour for 3 days was used. This syrup manufacturing company is Hakim co. in Iran and its concentratio
Intervention group 2: Syrup Acetaminophen 15mg/ kg orally, once an hour before surgery and then every 6 hours for 3 days was used. This syrup manufacturing company is Kimidaru co. in Iran and its conc

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- No Allergy to Non Steroid Anti-Inflammatory Drugs 2- No History of coagulopathy 3- No Renal and Hepatic disorder 4- No Severe Asthma (recently admission or treatment with oral corticosteroid) 5- No Family history of coagulopathy 6- No Evidence of Mental retardation Exclusion Criteria: 1- Severe and uncontrollable bleeding during and after surgery 2- Severe pain after surgery which needs additional analgesic

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: Six hours postoperative, at the end of first postoperative day, at the end of second postoperative day. Method of measurement: with visual analogue pain scale (1-10 score).

Secondary

MeasureTime frame
Intraoperative bleeding volume. Timepoint: During the surgery. Method of measurement: Amount of bleeding in CC, according to the number of sterile gases that is used during the surgery and amount of blood at suction bottle.;Bleeding at the first postoperative day. Timepoint: At the end of the first postoperative day. Method of measurement: questionnaire.;Bleeding during the first postoperative week. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire.;Nausea. Timepoint: At the end of first postoperative day and at the end of first postoperative week. Method of measurement: questionnaire.;Vomiting. Timepoint: At the end of first postoperative day and at the end of first postoperative week. Method of measurement: questionnaire.;Time to start eating of oral liquids. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire.;Time to start eating of semisolid foods. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire.;Time to start eating of solid foods. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire.;Time to going back to their normal life. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire.;Overall satisfaction of recovery. Timepoint: At the end of first postoperative week. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Mirashrafi

ENT research center, Imam Khomeini Hospital

f-mirashrafi@sina.tums.ac.ir+98 21 6658 1628

Outcome results

None listed

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