Background Opioids continue to be widely prescribed for chronic noncancer pain, despite the awareness that opioids provide only short-time pain relief, lead to dose accumulation, have numerous... Show moreBackground Opioids continue to be widely prescribed for chronic noncancer pain, despite the awareness that opioids provide only short-time pain relief, lead to dose accumulation, have numerous adverse effects, and are difficult to wean. As an alternative, we previously showed advantages of using pharmaceutical-grade cannabis in a population of chronic pain patients with fibromyalgia. It remains unknown whether combining an opioid with pharmaceutical-grade cannabis has advantages, such as fewer side effects from lesser opioid consumption in chronic pain.Methods Trial design: a single-center, randomized, three-arm, open-label, exploratory trial.Trial population: 60 patients with fibromyalgia according to the 2010 definition of the American College of Rheumatologists.Intervention: Patients will be randomized to receive up to 4 daily 5 mg oral oxycodone sustained release (SR) tablet, up to 5 times 150 mg inhaled cannabis (Bediol (R), containing 6.3% delta(9)-tetrahydrocannabinol and 8% cannabidiol), or the combination of both treatments. Treatment is aimed at self-titration with the daily maximum doses given. Treatment will continue for 6 weeks, after which there is a 6-week follow-up period.Main trial endpoint: The number of side effects observed during the course of treatment using a composite adverse effect score that includes the following 10 symptoms: dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, and paranoia.Secondary and tertiary endpoints include pain relief and number of oxycodone doses and cannabis inhalations.Discussion The trial is designed to determine whether self-titration of oxycodone and cannabis will reduce side effects in chronic pain patients with fibromyalgia. Show less
This thesis describes the relation of fear of childbirth (FOC), measured pre- and postpartum, with the preferred and actual place and mode of giving birth and with the use of pharmacological pain... Show moreThis thesis describes the relation of fear of childbirth (FOC), measured pre- and postpartum, with the preferred and actual place and mode of giving birth and with the use of pharmacological pain relief during labour. The studies were embedded in the Dutch obstetric system, where midwives have an independent profession and where home birth is an accepted option for women with a low-risk pregnancy. The general finding, consistent across all studies in this thesis, is that the level of FOC in pregnancy was strongly related to, and predictive of the level of postpartum FOC. Furthermore, women with severe FOC during pregnancy were prone to preferring a hospital birth, having pharmacological pain relief during labour and requesting an elective Caesarean Section. Congruence between one’s own preference (of place or mode of giving birth) and the actual delivery situation was not related to the degree of postpartum FOC. Instead, predictors for high postpartum FOC were: being referred from midwifery-led care to obstetrician-led care, emergency Caesarean Section, and a poor condition of the new-born. For guiding women with severe FOC through pregnancy and childbirth, a close collaboration between the obstetric caregiver and a psychotherapist is advised. Show less
Seijmonsbergen-Schermers, A.E.; Zondag, D.C.; Nieuwenhuijze, M.; Akker, T. van den; Verhoeven, C.J.; Geerts, C.; ... ; Jonge, A. de 2018
