The Effect of High-dose Remifentanil on the Reversal of Neuropathic Pain in Postherpetic Patients - RemiHighDose PHZ

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020042-94-AT

Enrollment

Registered

2010-07-27

Start date

2010-09-02

Completion date

Unknown

Last updated

2016-11-21

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

Conditions

Post herpetic hyperalgesia

Interventions

Trade Name: Remifentanil Product Name: Remifentanil Product Code: N01AH06 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: REMIFENTANIL CAS Number: 132875-61-7 Other des

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients suffering from PHN. • Pain = 4 out of 10 in numeric rating scale (NRS) • Female and male patients above the age of 18 • Ability to understand/write/read german 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Any of the following will exclude a subject from the study: • Zoster affecting trigeminal-, opticus region • Any somatic pain which is stronger than the neuropathic pain • Severe progressive disease • Acute cardiac decompensation • Known cardiac valve dysfunction • Known pulmonary hypertension • Cardiac conduction disturbance • Active herpetic lesion • Analgesic or antitussive opioid therapy • Bronchial asthmal • Known chronic obstructive pulmonary disease (COPD) >GOLD II • Severe psychiatric condition • Abuse of alcoholic beverages, drug abuse • Negative neuropathic symptoms • Pregnancy or breast feeding • Participation in a clinical trial in the 2 weeks preceding the study • Allergy against any medication used in the study protocol

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary outcome parameters as area of secondary hyperalgesia assessed by pinprick, area of dynamic allodynia, numeric rating scale (NRS), mechanical pain threshold, heat pain perception threshold (HPPT), heat pain tolerance threshold (HPTT) at baseline and +140min., coolness, warmth, and laser doppler perfusion imaging (LDPI, PeriScan PIM II System, Perimed, Stockholm, Sweden) will be analyzed analogously.;Primary end point(s): Our primary outcome parameter being S/R function, we will analyze the within-subject difference at baseline -20min versus 140min (80min after the end of remifentanil).;Main Objective: The aim is to study the hypothesis, that PHZ hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml for 60 minutes.	—

Measure

Time frame

Secondary Objective: Secondary outcome parameters as area of secondary hyperalgesia assessed by pinprick, area of dynamic allodynia, numeric rating scale (NRS), mechanical pain threshold, heat pain perception threshold (HPPT), heat pain tolerance threshold (HPTT) at baseline and +140min., coolness, warmth, and laser doppler perfusion imaging (LDPI, PeriScan PIM II System, Perimed, Stockholm, Sweden) will be analyzed analogously.;Primary end point(s): Our primary outcome parameter being S/R function, we will analyze the within-subject difference at baseline -20min versus 140min (80min after the end of remifentanil).;Main Objective: The aim is to study the hypothesis, that PHZ hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml for 60 minutes.

—

Countries

Austria

Outcome results

None listed

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