Clonidine in repeated doses for children in pai

Conditions: Pain in children
MedDRA version: 18.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-005416-42-SE

Lead Sponsor: ppsala University. Department of Women's and children's health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age 6 month-18 years
Admitted to the oncology and hematology ward at Uppsala University Childrens hospital.
clonidine 1 ug/kg x 4 prescribed by responsible doctor.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

Temperature >39 degrees celcius
sepsis
Poor swedish language skills

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. What is the bioaavailaiblity of mixture klonidine 20 ug/ml in children?<br>2. Does the area under the curve correlate to the weight/body area of the child? <br>3. What is the through value when clondine 1 ug/kg is administred every sixth hour? ;Secondary Objective: 4. Does the area under the curve correlate to the child’s pain?<br>5. Does the area under the curve correlate to the child’s sedation level?<br>6. Does the area under the curve correlate to the child's opioid need?;Primary end point(s): 1. Clonidine concentration in blood;Timepoint(s) of evaluation of this end point: 10,20,30,60,120,240 min after first dose. Prior to morning dose the following days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 2. Pain <br>Children- 4-6 år - Facial pain scale revisited (FPS-r)<br>Children- >6 numerical rating scale (NRS)<br>Parents- NRS<br>Nurse - Face leg arm cry consolability (FLACC) <br><br>3. Sedation <br>Nurse -University of Michigan Sedation Scale<br><br>4. opioid consumtion/day (morphine eqvivalents)<br>5. side effects of treatment. <br>Parents and children -Questionnaire<br>;Timepoint(s) of evaluation of this end point: 2: 0,60,120 and 240 min after fist dose. Before each new dose and 90 minutes after each given dose<br>3: 0,60,120 and 240 min after fist dose. Before each new dose. <br>4: daily<br>5. Daily