Postoperative smerter efter bækkenosteotomi med lokal infiltrationsanalgesi hos børn med cerebral parese. Et prospektivt, randomiseret og dobbeltblindet studie.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006913-26-DK

Enrollment

Registered

2009-01-13

Start date

2009-01-20

Completion date

Unknown

Last updated

2013-02-11

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

Conditions

cerebral parese MedDRA version: 9.1 Level: LLT Classification code 10009445 Term: Closed frac of bos with intcran inj of oth and unspec nature, with moderate loc MedDRA version: 9.1 Level: LLT Classification code 10040348 Term: Serum noradrenaline increased

Interventions

Trade Name: Naropin Product Name: Naropin Product Code: 9445 Pharmaceutical Form: Injection* Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Infiltration use Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Planlagt bækken og/eller femur osteotomi på Ortopædkirurgisk afdeling, Århus Sygehus. 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

Exclusion criteria: Planlagt bilateral operation

Design outcomes

Primary

Measure	Time frame
Main Objective: At sammenligne den analgetiske virkning af naropin med den analgetiske virkning af saltvand på postoperative smerter hos børn med cerebral parese.;Secondary Objective: At undersøge hvor effektiv R-FLACC scoren er til at vurdere smerter hos børn med cerebral parese.;Primary end point(s): Smerteintensitet 4 timer efter operationen.	—

Countries

Denmark

Outcome results

None listed

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