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Dexamethasone for postoperative pain relief following tonsillectomy in children - Dexamethasone for postoperative pain relief following tonsillectomy in childre

Active, not recruiting
Conditions
(Adeno)Tonsillectomy and Pain
Registration Number
EUCTR2007-001170-92-NL
Lead Sponsor
Erasmus MC
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
112
Inclusion Criteria

Main inclusion criteria are:
- Age 3 to 7 years,
- Electieve (adeno)tonsillectomy,
- ASA status 1 of 2 according to criteria of the American Society of Anesthesiologists

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Coagulation problems
- Use of adecetaminophen or diclofenac within 24 hours of surgery
- Liver or kidney function problems
- Mental retardation

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To assess whether the administration of dexamathosone in combination with acetaminophen and diclofenac provides better pain relief after (adeno)tonsillectomy than the combination of acetaminophen and diclofenac only.<br>;Secondary Objective: To assess whether children who received dexamathosone in combination with acetaminophen and diclofenac before (adeno)tonsillectomy drink and eat faster than those who received acetaminophen and diclofenac only.<br>;Primary end point(s): Pain<br>Drinking<br>Eating
Secondary Outcome Measures
NameTimeMethod
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