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Epifysiodesis for adolescents; What is the most effective postoperative pain treatment? An RCT

Epifysiodesis for adolescents; What is the most effective postoperative pain treatment? An RCT - Postoperative pain treatment after epiphysiodesis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42155
Enrollment
70
Registered
2015-03-23
Start date
2015-10-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

postoperative pain

Interventions

a) epidural painmanagement will be started at the beginning of the surgical procedure and will be in situ for three days. Thereafter painmedication will be prescribed according to the WHO
b) painmanagement with the use of a PCA (pain pump) started directly after the surgical procedure, eventually oral medication according to the WHO will be given.

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: age between12-16 year; *indicated for an epiphysiodesis*, namele boys of which the estimated finally body length will be minimally 200 cm; and for girls 195 cm.

Exclusion criteria

Exclusion criteria: insufficient command of Dutch language; not willing to be randomized; contra-indications for an epiphysiodesis procedure.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the VAS (visual analoge scores) for pain during the first 5 days after the procedure.

Secondary

MeasureTime frame
Secundary outcome measures are: amount of pain 2 weeks , 6 weeks and 6 months after the procedure; co-medication use; adverse events; satisfaction rate of the patient; duration of Hospital stay and knee function.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)