FindTrial
Sign In

The effect of late infusion of Naloxon, a drug that neutralizes the effect of morphine, on pain sensitivity after a first degree burn injury

The effect of late naloxon-infusion on secondary hyperalgesia after a first degree burn injury

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000839-54-DK
Enrollment
Unknown
Registered
2012-04-23
Start date
2012-06-07
Completion date
Unknown
Last updated
2013-05-13

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

Conditions

Induced pain in volunteers MedDRA version: 14.1 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Trade Name: Naloxon Product Name: Naloxon Product Code: V03AB15 Pharmaceutical Form: Infusion INN or Proposed INN: NALOXONE CAS Number: 465-65-6 Concentration unit: mg/ml milligram(s)/millilitre Conce

Sponsors

Rigshospitalet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy Age betwen 20 and 35 Volunteers that have given there written concent to participate in the clinical trial and understand the trial. Urinary test with no trace of opioids Negative pregnancy test ASA 1-2 Body mass index (BMI): 18 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Volunteers that can not cooperate Volunteers that do not understand and read danish Women who are planning to be pregnant, are pregnant or are breastfeeding Women how do not use birthcontrol Have been in another clinical trial the last 60 days Any form of injury or any other influence of the nerves on the calf Any neurological disease use of any psychoactive drugs Abuse of alcohol or drug Chronical pain regular use of analgesia (more than twice a week) Know allergy to morphine or other morphine drug incl. Naloxon Skin lesion on the calf Has taken medicin prescription a week before the trial Has taken over the counter medicin 48 hours before the trial Psychological instabel - investigators evaluation

Design outcomes

Primary

MeasureTime frame
Timepoint(s) of evaluation of this end point: 73 hours after induced burn injury;Main Objective: The main objective is to investigate if the administration of naloxon can reinduce secundary hyperalgesia areas after a first degree burn injury in volunteers ;Secondary Objective: None;Primary end point(s): Primary end point is the areas of the secondary hyperalgesia—

Secondary

MeasureTime frame
Secondary end point(s): WDT - Warm - Detection Threshold HPT - Heat Pain Threshold MPT - Mecanic Pain Threshold HADS - Hospital Anxiety and Depression Scale ;Timepoint(s) of evaluation of this end point: 3 hours after incuced burn injury—

Countries

Denmark

Contacts

Public ContactKaren Lisa Hilsted

Rigshospitalet

karen.lisa.hilsted@rh.regionh.dk+4535459502

Outcome results

None listed

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