The pharmacokinetics of single and multiple doses of intravenous paracetamol in children - Pharmacokinetics of I.V paracetamol in childre

• Conditions: There is no medical condition to be investigated. This is a pharmacokinetic study to be performed in children routinely treated with intravenous paracetamol for post surgical pain in line with local treatment protocol.

• Registration Number: EUCTR2009-012585-30-GB
• Lead Sponsor: HS Grampian Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children under 16 years of age administered intravenous paracetamol for routine post-operative pain relief following elective surgery, according to local treatment protocol.
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

Patients will be excluded from the study for:
1: The anaethetist does not anticipate that the child will require post surgical intravenous paracetamol;
2: Routine evidence of liver dysfunction;
3: Routine evidence of renal impairment;
4: Known hypersensitivity to paracetamol or any of the components of the intravenous formulation of paracetamol:
5: Prior use of paracetamol within 24 hours of the study; and
6: Parental or child objection to study participation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): Blood paracetamol concentration with time;Main Objective: The objective of this research is to assess how the age, weight, height and body surface area of a child affects the metabolism an excretion of intravenous paracetamol given to relieve post-operative pain.