scholarly journals Subcutaneous sumatriptan for the treatment of postcraniotomy pain (SUPS trial): protocol for a randomised double-blinded placebo controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e032388
Author(s):  
Ana Licina ◽  
Jeremy Russell ◽  
Andrew Silvers ◽  
Xin Jin ◽  
Jason Denny
Keyword(s):  
Pain Management ◽  
Phase Iii ◽  
Trial Protocol ◽  
Study Drug Administration ◽  
Management Protocol ◽  
Opioid Administration ◽  
Patient Reported ◽  
Subcutaneous Sumatriptan ◽  
Registration Number ◽  
Double Blinded

IntroductionPostcraniotomy pain protocols use opioids, which are considered suboptimal analgesia following this procedure. Multimodal analgesia components are sparse. Our null hypothesis states that sumatriptan is not different to placebo in addition to usual intravenous opioids, for the treatment of acute postcraniotomy pain.Methods and analysisThis is a prospective single-centre randomised double-blinded placebo-controlled phase III clinical trial comparing subcutaneous sumatriptan injection in the recovery area with placebo for the treatment of postcraniotomy pain. Eligible adult patients (18 years and older) undergoing craniotomy will be identified preoperatively. Both patient groups will receive a subcutaneous injection at a point where recovery-nursing staff would initiate the usual intravenous opioid analgesia as per standardised pain management protocol. In both groups, further pain management will be followed by the usual intravenous opioid administration. Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration. Postcraniotomy pain will be measured at regular intervals using the Visual Analogue Scale (VAS) in recovery area. The minimal clinically important difference of 10 mm on the VAS between the two groups will be considered as statistically significant. We will include selected clinical and patient-reported outcomes as secondary endpoints. Univariate regression will be conducted on each one of the clinically plausible potential confounders. We will enrol a total 136 patients, with the study duration of 2 years. This trial will commence recruitment on the 1 July 2019.Ethics and disseminationThis trial protocol has achieved approval by the Austin Health Research Committee, HREC/17/Austin/596. This trial was prospectively registered with Australian New Zealand Clinical Trials Registry on the 10/05/2018 with a unique trial identifier U1111-1209-9072 and registration Number ACTRN12618000793213P. Findings of this study will be disseminated in peer-reviewed academic journals.Trial registration numberU1111-1209-9072, ACTRN12618000793213P

Intravenous Acetaminophen for Postoperative Pain Management in Patients Undergoing Living Laparoscopic Living-Donor Nephrectomy

2016 ◽  
Vol 51 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Van Vu ◽  
William L. Baker ◽  
Elizabeth M. Tencza ◽  
Caroline Rochon ◽  
Patricia A. Sheiner ◽  
...  
Keyword(s):  
Pain Management ◽  
Postoperative Pain ◽  
Living Donor ◽  
Postoperative Pain Management ◽  
Living Donor Nephrectomy ◽  
Pain Scores ◽  
Opioid Administration ◽  
Patient Reported ◽  
Average Pain ◽  
Control Versus

Background: Postoperative pain is a common complication of laparoscopic living-donor nephrectomies (LLDNs). Objective: To determine whether intravenous (IV) acetaminophen administration post-LLDN influenced length of stay (LOS) when used for pain management. Methods: This single-center, retrospective study compared patients undergoing LLDN who had received IV acetaminophen for pain control versus those who did not between June 1, 2011, and November 30, 2015. Patient LOS, 30-day readmissions, frequency of pain assessments, patient-reported pain scores, and opioid administration were assessed. Results: A total of 90 patients were included in the analysis (IV acetaminophen, n = 48; non-IV acetaminophen, n = 42). Patients who did not receive IV acetaminophen were more often older (48.8 ± 12.1 vs 39.3 ± 12.1 years; P = 0.012) and female (71.4% vs 47.9%; P < 0.001). The average LOS was similar between the 2 groups (median = 3.0; interquartile range = [3, 4] vs 3.5 [3, 4]; P = 0.737). The 30-day readmissions were higher in the IV acetaminophen group (16.7%) compared with the group not receiving IV acetaminophen (2.4%; P = 0.033). After the first postoperative day, the frequencies of pain assessments performed were similar among the 2 groups. There was no difference in average pain scores between the groups at any time after LLDN. Conclusions: Patients receiving IV acetaminophen were found to have no improvements in hospital LOS, average pain score, or opioid requirements compared with patients not receiving IV acetaminophen. Patients who received IV acetaminophen were also found to have a higher 30-day readmission rate.

Evaluation of the effect of intravenous calcium and magnesium (CaMg) on chronic and acute neurotoxicity associated with oxaliplatin: Results from a placebo-controlled phase III trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4025-4025
Author(s):  
A. Grothey ◽  
D. A. Nikcevich ◽  
J. A. Sloan ◽  
J. W. Kugler ◽  
P. T. Silberstein ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Acute Effect ◽  
Patient Reported Outcome ◽  
Phase Iii ◽  
Muscle Cramps ◽  
Patient Reported ◽  
Blinded Manner ◽  
Acute Neurotoxicity ◽  
Double Blinded ◽  
Dose Limiting Toxicity

4025 Background: Cumulative sNT is the dose-limiting toxicity of oxaliplatin which commonly leads to early discontinuation of oxaliplatin-based therapy in the palliative and adjuvant setting. We recently demonstrated the protective effect of CaMg against oxaliplatin-induced sNT as assessed by NCI-CTC (Nikcevich ASCO 2008). It is unclear, though, if CaMg reduced acute and/or chronic, cumulative sNT. Methods: 104 pts with colon cancer undergoing adjuvant therapy with FOLFOX were randomized to IV CaMg (1g calcium gluconate plus 1g magnesium sulfate pre- and post-oxaliplatin) or placebo (PL) in a double-blinded manner. NCI-CTC, an oxaliplatin-specific sNT scale and patient-reported outcome (PRO) questionnaires were used to differentially assess the effect of CaMg on acute (effect on sNT on days 1–4 after oxaliplatin) and chronic sNT (area between curves over whole course of therapy). Results: A total of 102 pts (50 CaMg, 52 PL; 96 mFOLFOX6, 6 FOLFOX4) were available for analysis. Apart from a strong reduction in muscle cramps with CaMg (p=0.002), no difference was found between CaMg and PL in PRO with regard to items reflecting acute sNT (e.g. sensitivity to cold, swallowing of cold liquids, throat discomfort) on days 1–4 after oxaliplatin of any treatment cycle. In contrast, CaMg was able to significantly reduce cumulative sNT in form of numbness in fingers (p=0.02), impaired ability to button shirts (p=0.05), tingling in fingers (p=0.06), and muscle cramps over the course of therapy (p=0.01). Conclusions: In our phase III, placebo-controlled trial, CaMg was able to significantly reduce chronic, cumulative sNT related to oxaliplatin as evaluated by specific PRO questionnaires. No effect was noted on phenomena associated with acute sNT. CaMg can be recommended as neuroprotectant against oxaliplatin-related chronic sNT, oxaliplatin's dose-limiting toxicity. [Table: see text]

scholarly journals Stemming the Tide of Opioid Addiction—Dramatic Reductions in Postoperative Opioid Requirements Through Preoperative Education and a Standardized Analgesic Regimen

2019 ◽  
Vol 185 (3-4) ◽  
pp. 436-443 ◽  
Author(s):  
Rowan R Sheldon ◽  
Jessica B Weiss ◽  
Woo S Do ◽  
Dominic M Forte ◽  
Preston L Carter ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Pain Management ◽  
Postoperative Pain ◽  
Pain Control ◽  
Inclusion Criteria ◽  
Opioid Use ◽  
Opioid Prescription ◽  
Management Protocol ◽  
Patient Reported ◽  
Nonopioid Analgesics

Abstract Introduction Surgery is a known gateway to opioid use that may result in long-term morbidity. Given the paucity of evidence regarding the appropriate amount of postoperative opioid analgesia and variable prescribing education, we investigated prescribing habits before and after institution of a multimodal postoperative pain management protocol. Materials and Methods Laparoscopic appendectomies, laparoscopic cholecystectomies, inguinal hernia repairs, and umbilical hernia repairs performed at a tertiary military medical center from 01 October 2016 until 30 September 2017 were examined. Prescriptions provided at discharge, oral morphine equivalents (OME), repeat prescriptions, and demographic data were obtained. A pain management regimen emphasizing nonopioid analgesics was then formulated and implemented with patient education about expected postoperative outcomes. After implementation, procedures performed from 01 November 2017 until 28 February 2018 were then examined and analyzed. Additionally, a patient satisfaction survey was provided focusing on efficacy of postoperative pain control. Results Preprotocol, 559 patients met inclusion criteria. About 97.5% were provided an opioid prescription, but prescriptions varied widely (256 OME, standard deviation [SD] 109). Acetaminophen was prescribed often (89.5%), but nonsteroidal anti-inflammatory drug (NSAID) prescriptions were rare (14.7%). About 6.1% of patients required repeat opioid prescriptions. After implementation, 181 patients met inclusion criteria. Initial opioid prescriptions decreased 69.8% (77 OME, SD 35; P &lt; 0.001), while repeat opioid prescriptions remained statistically unchanged (2.79%; P = 0.122). Acetaminophen prescribing rose to 96.7% (P = 0.002), and NSAID utilization increased to 71.0% (P &lt; 0.001). Postoperative survey data were obtained in 75 patients (41.9%). About 68% stated that they did not use all of the opioids prescribed and 81% endorsed excellent or good pain control throughout their postoperative course. Conclusions Appropriate preoperative counseling and utilization of nonopioid analgesics can dramatically reduce opioid use while maintaining high patient satisfaction. Patient-reported data suggest that even greater reductions may be possible.

The influence of continuous local wound infusion on postoperative pain in patients undergoing transfemoral amputation

VASA ◽  
2015 ◽  
Vol 44 (5) ◽  
pp. 381-386 ◽  
Author(s):  
Christian Uhl ◽  
Thomas Betz ◽  
Andrea Rupp ◽  
Markus Steinbauer ◽  
Ingolf Töpel
Keyword(s):  
Pain Management ◽  
Pilot Study ◽  
Local Anaesthetic ◽  
Phantom Pain ◽  
Transfemoral Amputation ◽  
Postoperative Wound ◽  
Stump Pain ◽  
Management Protocol ◽  
Group 2 ◽  
Group 1

Abstract. Summary: Background: This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics. Patients and methods: We included 42 patients in this prospective observational pilot study. Patients were divided into two groups. One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment (Group 1). Group 2 was treated with analgesics in accordance with the WHO standard pain management protocol, exclusively. Results: The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group 1 for the first 5 days. Furthermore, the intake of opiates was significantly reduced in Group 1 (day 1, Group 1: 42.1 vs. Group 2: 73.5, p = 0.010; day 2, Group 1: 27.7 vs. Group 2: 52.5, p = 0.012; day 3, Group 1: 23.9 vs. Group 2: 53.5, p = 0.002; day 4, Group 1: 15.7 vs. Group 2: 48.3, p = 0.003; day 5, Group 1 13.3 vs. Group 2: 49.9, p = 0.001). There were no significant differences between the two groups, neither in phantom pain intensity at discharge nor postoperative complications and death. Conclusions: Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation. Phantom pain was not significantly affected.

scholarly journals Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study

2020 ◽  
Vol 8 (1) ◽  
pp. e000773
Author(s):  
Carol H Wysham ◽  
Julio Rosenstock ◽  
Marion L Vetter ◽  
Hui Wang ◽  
Elise Hardy ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Phase Iii ◽  
Open Label ◽  
Open Label Study ◽  
Registration Number ◽  
Efficacy Measures ◽  
Design And Methods ◽  
To Receive

IntroductionInvestigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.Research design and methodsIn this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.ResultsIn total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28–52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of –1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of –1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.ConclusionsSwitching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.Trial registration numberNCT01652716.

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