Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia in Patients following Recovery from Impacted Mandibular Third Molar Extraction.A Randomized, Placebo-controlled, Double-blind Crossover Study. - HighNxTME

Rigshospitalet, Copenhagen University Hospitals0 个研究点目标入组 94 人开始时间: 2015年12月10日最近更新: 2024年2月19日

试验速览

暂无简介。

•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)
•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

•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

发起方

Rigshospitalet, Copenhagen University Hospitals