Effect of High-dose Naloxone Following Third Molar Extraction

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: mads u werner
• Collaborator: University of Kentucky
• Treatments: Naloxone

Criteria

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