Pain
Conditions
Keywords
dihydrocodeine, opioids, long acting, opioids, short acting, Chronic pain, non-malignant pain
Brief summary
We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We measure pain relief, health related quality of life, sleep, breakthrough pain and depression with validated questionnaires to compare the two treatment arms. Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality of sleep, breakthrough pain and quality of life will also be improved with long acting dihydrocodeine.
Interventions
DRUGDihydrocodeine
Group 1: 2\* 60 mg dihydrocodeine long acting + up to four placebo short action Group 2: 3\* 60 mg dihydrocodeine long acting + up to six placebo short action Group 3: 4\* 60 mg dihydrocodeine long acting + up to eight placebo short action Group 4: 2 placebo for long acting + up to 4\*30 mg dihydrocodeine short acting Group 5: 3 placebo for long acting + up to 6\*30 mg dihydrocodeine short acting Group 6: 3 placebo for long acting + up to 8\*30 mg dihydrocodeine short acting
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic pain * Use 5-10 P.Forte every day for the last two weeks * 18-75 years.
Exclusion criteria
* Cancer * Hepatic failure * Severe mental disorders * History of known substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 9 weeks | Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sleep quality and duration | 9 weeks | Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured. |
| quality of life | 9 weeks | Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured. |
| Depression and moods | 9 weeks | Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured |
Countries
Norway
Outcome results
None listed