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Clinical Trials/EUCTR2020-004826-47-DK
EUCTR2020-004826-47-DK
Active, not recruiting
Phase 1

Intraoperative methadone for postoperative pain management in spinal fusion surgery: a prospective, double-blind, randomised controlled trial - METASPINE

one Nikolajsen0 sites150 target enrollmentOctober 22, 2020
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Conditionsow back painTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsMethadone Streuli Sol Inj 10 mg/ml 10 AMPS 1 ML

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
ow back pain
Sponsor
one Nikolajsen
Enrollment
150
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 22, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
one Nikolajsen

Eligibility Criteria

Inclusion Criteria

  • •All patients (\=18 years) scheduled for elective spine surgery are screened for inclusion.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 90
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 60

Exclusion Criteria

  • •Allergy to study drugs
  • •American Society of Anaesthesiologists (ASA) physical status IV or V
  • •Prolonged QTc\-interval assessed by electrocardiogram (Male: \>450 milliseconds, Female: \>460 milliseconds)
  • •Inability to provide informed consent
  • •Severe respiratory insufficiency (Oxygen treatment at home)
  • •Heart failure
  • •Acute alcohol intoxication/delirium tremens
  • •Increased intracranial pressure
  • •Acute liver disease
  • •Acute abdominal pain

Outcomes

Primary Outcomes

Not specified

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