CompletedPhase 2

Effect of High-dose Naloxone Following Third Molar Extraction

Denmark23 participantsStarted 2017-10-12

Plain-language summary

Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache. Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization. In the present study, the investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. The investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.

Who can participate

Age range18 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: * Healthy male * Age, minimum 18 yrs and maximum 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. * Standardized surgical procedure. * 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/m2 EXCLUSION CRITERIA: * Participants, who do not speak or understand Danish * Participants, who cannot cooperate with the investigation * Participants, who have had previous surgery in the mandibular region * 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 * Skin lesions or tattoos in the assessment areas * 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

What they're measuring

Change in the composite measure of pain (numerical rating scale (NRS); 0 = no pain; 10 = worst perceivable pain)

Timeframe: 1st session: 4 weeks after TME-surgery; 2nd session: 1 week later. At each session assessments are made at: -20 to -8 min; 15 to 25 min (TCI-step 1); 40 to 50 min (TCI-step 2); and 65 to 75 min (TCI-step 3) relative to start of TCI.

Trial details

NCT IDNCT02976337

Sponsormads u werner

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-27

View on ClinicalTrials.gov More Healthy Subjects trials