Opioid induced hypersensitivity: possible to avoid by different withdrawal regimens?

Opioid Induced Hyperalgesia: possible to avoid by gradual reduction compared to acute withdrawal from remifentanil? - Opioid Induced Hyperalgesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002734-39-NO

Enrollment

Registered

2011-10-31

Start date

2012-03-09

Completion date

Unknown

Last updated

2021-10-08

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

Conditions

Opioid Induced Hyperalgesia MedDRA version: 14.0 Level: LLT Classification code 10033376 Term: Pain aggravated System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Trade Name: Ultiva(generic name: remifentanil) Product Name: Ultiva Product Code: 2L3269 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ultiva CAS Number: 132539-07-2

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy men, volunteers, age 18-60. 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 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Drug abuse; permanent users of opioids/NSAID/steroids or other types of analgetics; chronic diseases; allergy to opioids.

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparing gradual reduction from remifentanil infusion to acute withdrawal with regards to opioid induced hyperalgesia.;Secondary Objective: None;Primary end point(s): Avoid opioid induced hyperalgesia.;Timepoint(s) of evaluation of this end point: After end of trials, 105 minutes after stopped infusion.	—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Norway

Contacts

Public ContactClinical trial information

Oslo University Hospital

Marlin.Comelon@gmail.com4722119690

Outcome results

None listed

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