Clonidine in repeated doses for children in pain

Clondine in repeated doses for children in pain - a farmacokinetic study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005416-42-SE

Enrollment

Registered

2015-03-12

Start date

2015-05-08

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain in children MedDRA version: 18.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Trade Name: Catapresan Product Name: Catapresan Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Clonidine CAS Number: 4205-91-8 Other descriptive name: CLONIDINE HYDROCHLORI

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Temperature >39 degrees celcius sepsis Poor swedish language skills

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. What is the bioaavailaiblity of mixture klonidine 20 ug/ml in children? 2. Does the area under the curve correlate to the weight/body area of the child? 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? 5. Does the area under the curve correlate to the child’s sedation level? 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	—

Measure

Time frame

Main Objective: 1. What is the bioaavailaiblity of mixture klonidine 20 ug/ml in children? 2. Does the area under the curve correlate to the weight/body area of the child? 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? 5. Does the area under the curve correlate to the child’s sedation level? 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

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

Measure

Time frame

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

—

Countries

Sweden

Contacts

Public ContactKlonidinstudien

Uppsala university, Department of Women's and children's health

gustaf.ljungman@kbh.uu.se46018611 5804

Outcome results

None listed

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