Effect of high-dose naloxone - an antidote to morphine - on pain sensitivity after removal of a wisdom tooth.

Phase 1

• Conditions: Healthy volunteers (n = 94) are included. The main study includes 14 subjects who have had an uncomplicated, impacted mandibular, third molar extraction 4-5 weeks prior to participation in the study. The sub-study includes 80 subjects who will receive a first degree heat injury.; MedDRA version: 18.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-005426-19-DK
• Lead Sponsor: Rigshospitalet, Copenhagen University Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-10
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 94

Inclusion Criteria

•Healthy male
•Age above 18 yrs and below 65 yrs
•Signed informed consent
•Participants submitted to unilateral, primary, impacted, uncomplicated mandibular third molar extraction 4 weeks (+ 3 days) prior to examination Day 1 (main study).
•Standardized surgical procedure (main study).
•Urin-sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextromethorphan)
•ASA I-II
•Body mass index (BMI): 18 < BMI < 30 kg/sq.m

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 94
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Participants, who cannot cooperate with the investigation
•Participants, who have had previous surgery in the mandibular region (main study)
•Participants with pain at rest > 3 (NRS [0: no pain; 10: worst perceivable pain])
•Activity-related pain in the surgical field > 5 (NRS)
•Allergic reaction against morphine or other opioids (including naloxone),
•Abuse of alcohol or drugs – according to investigator’s evaluation
•Use of psychotropic drugs (exception of SSRI)
•Neurologic or psychiatric disease
•Chronic pain condition
•Regular use of analgesic drugs
•Nerve lesions in the assessment sites (e.g., after trauma, dental surgery)
•Use of prescription drugs one week before the trial
•Use of over-the-counter (OTC) drugs 48 hours before the trial
•Scarring or tattoos in the examination areas

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified