scholarly journals Intrathecal betamethasone for cancer pain: A study of its analgesic efficacy and safety

2018 ◽  
Vol 63 (5) ◽  
pp. 659-667
Author(s):  
Hitoshi Taguchi ◽  
Keiko Oishi ◽  
Koh Shingu ◽  
Hideo Matsumoto ◽  
Munehiro Masuzawa
Keyword(s):  
Cancer Pain ◽  
Analgesic Efficacy ◽  
Efficacy And Safety

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

Targin - efficacy and safety of therapy following conversion from earlier opioid in patients with cancer pain. Observational study report

Ból ◽  
2016 ◽  
Vol 17 (3) ◽  
pp. 11-18
Author(s):  
Elwira Góraj
Keyword(s):  
Observational Study ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Analgesic Efficacy ◽  
Previous Treatment ◽  
Tolerability Profile ◽  
Efficacy And Safety ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Strong Opioids

The aim of the study was evaluation of the efficacy, safety and compliance of the treatment with combination of oxycodone / naloxone (Targin) after the rotation from weak or strong opioid in a multicenter, open, prospective, observational study. Research group consisted of adult patients with chronic, severe cancer pain with presents of symptoms of Opioid Induced Constipation (OIC) associated with the previous treatment were enrolled into the rotation to oxycodone /naloxone (Targin). The study consisted of 4 visits in total, the observation was scheduled for 3 months. The following data were collected: daily dose of oxycodone / naloxone, pain intensity (NRS), adverse effects, number of omitted doses (compliance). After completion of all four visits an assessment of the efficacy and safety of the Targin treatment was made. A reduction in pain intensity (NRS) from baseline of 5.2 (average pain intensity at V1) to 2.1 (average pain intensity for V4) was observed. In sub-groups selected according to previous pain therapy, a reduction in pain intensity out of 5,0 (average pain intensity for V1 in patients treated earlier with strong opioids) to 2.1 (V4) and 5.7 (average pain intensity for V1 in patients treated earlier with weak opioids) to 2.1 (V4). The proportion of patients who did not require laxatives decreased from visit to visit. Patients who received Targin monotherapy after the rotation showed a greater compliance than patients who, in addition to Targin, also were prescribed with another opioid. In the group of patients who completed all four visits, efficacy was assessed as very good or good in 91.7% cases, similarly in 95.8% cases tolerability was evaluated as very good or good. Concluding, rotation to Targin from both, the weak and strong opioids, resulted in a very good and good pain control with reduction in the frequency and severity of OIC. The final result could be multifactorial, but we can confirm the good analgesic efficacy and favorable tolerability profile of Targin with significant reduction of OIC symptoms.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

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