A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
NCT ID: NCT01267136
Last Updated: 2014-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
84 participants
INTERVENTIONAL
2011-01-31
2012-05-31
Brief Summary
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Hypotheses
H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen.
H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Capital® with Codeine Suspension
Codeine with acetaminophen
Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
Tramadol suspension
Tramadol suspension
Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
Interventions
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Codeine with acetaminophen
Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
Tramadol suspension
Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Child must be between the ages of 4 and 15 at the time of enrollment.
* Child and caregiver must be English-speaking.
* The same caregiver (e.g., mother) must agree to complete all study assessments with child to ensure consistency.
Exclusion Criteria
* Child had significant adverse effects to codeine, tramadol, or acetaminophen in the past.
* Child has a known underlying seizure disorder (not febrile seizure).
* Child has known underlying renal or liver dysfunction (with creatinine, aspartate aminotransferase \[AST\]/amino alanine transferase \[ALT\], above normal value for age, respectively).
* Child or caregiver is not English-speaking.
* The same caregiver (e.g., mother) is unable to complete all follow-up assessments.
4 Years
15 Years
ALL
No
Sponsors
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Children's Hospitals and Clinics of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Stefan J Friedrichsdorf, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospitals and Clinics of Minnesota
Locations
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Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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Other Identifiers
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1010-086
Identifier Type: -
Identifier Source: org_study_id
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