nociceptive pain (disorders) Pain
Conditions
Interventions
(1) 1000 mg (2 capsules of 500 mg) paracetamol (2) placebo.
Sponsors
Centre for Human Drug Research
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: * Agree to and be capable of signing an informed consent form. * Written informed consent from parents having parental responsibility or from the legal guardian; * Healthy male and female subjects; * Age: 16 or 17 years at screening; * Attending high school; * Body mass index between 18-30 kg*m-2; * Able to refrain from strenuous physical exercise from 48 hours prior to nociceptive testing until dismissal from the CHDR clinic; * Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic; * Ability to communicate well with the investigator in the Dutch language. * Previous use of paracetamol without adverse effects
Exclusion criteria
Exclusion criteria: * Inability to comply with the requirements of the study; * Known liver and/or renal disease as determined by medical history taking; * Clinically significant findings as determined by medical history taking * Any current, clinically significant, known medical condition, in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (paraesthesia, etc.); * Medical history of fainting or syncope e.c.i.; * Previous allergic reaction to paracetamol; * Pregnancy and/or breast feeding in females; * Subjects indicating nociceptive tests intolerable at screening or achieving tolerance at >70% of maximum input intensity for any nociceptive test; * Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening; * Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic; * History or clinical evidence of alcoholism or drug abuse; * Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic; * Use of prescription, illicit or herbal medication within 7 days of nociceptive assessments; * Use of over-the-counter analgesic medications within 3 days of nociceptive assessments. * Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Pharmacokinetics: saliva paracetamol concentrations * Pharmacodynamics: pain threshold and tolerance levels for: o heat pain (skin) (degrees Celsius), o pressure pain (muscle) (kPa), o electrical pain (skin) (mA), o cold pressor pain (sec). The results of the questionnaire on participation. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A. | — |
Countries
Netherlands
Outcome results
None listed