NCT00964639

Brief Summary

This study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with Naropine. Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

3.4 years

First QC Date

August 24, 2009

Last Update Submit

January 25, 2013

Conditions

Postoperative PainCerebral Palsy

Keywords

PainPostoperativeLocal infiltration analgesiaCerebral palsyr-FLACC

Outcome Measures

Primary Outcomes (1)

  • Difference in pain measured with r-FLACC between the 2 groups

    2 years

Study Arms (2)

Saline

PLACEBO COMPARATOR
Drug: Saline

Naropin

ACTIVE COMPARATOR
Drug: Ropivacaine

Interventions

RopivacaineDRUG

During the surgery infiltration with Naropine 2 mg/ml. The dosage in the infiltration is 2 mg/kg. Thereafter bolus 3 times a day

Naropin
SalineDRUG

During the surgery infiltration with saline. Thereafter bolus 3 times a day

Saline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age under 18
  • informed consent
  • Postoperative cast with spica

You may not qualify if:

  • Previous surgery in the same hip
  • Other surgical procedure planned at the same time
  • Bilateral surgery
  • Previous allergic reaction to local analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of childrens orthopaedics, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativeCerebral PalsyPain

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

DK(1)