scholarly journals A fixed nitrous oxide/oxygen mixture as an analgesic for patients with postherpetic neuralgia: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hai-Xiang Gao ◽  
Jun-Jun Zhang ◽  
Ning Liu ◽  
Yi Wang ◽  
Chun-Xiang Ma ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nitrous Oxide ◽  
Pain Management ◽  
Postherpetic Neuralgia ◽  
Analgesic Effect ◽  
Intervention Group ◽  
Oxygen Mixture ◽  
Control Group ◽  
Routine Treatment ◽  
Nitrous Oxide Oxygen

Abstract Background The pain management of postherpetic neuralgia (PHN) remains a major challenge, with no immediate relief. Nitrous oxide/oxygen mixture has the advantages of quick analgesic effect and well-tolerated. The purpose of this study is to investigate the analgesic effect and safety of nitrous oxide/oxygen mixture in patients with PHN. Methods/design This study is a single-center, two-group (1:1), randomized, placebo-controlled, double-blind clinical trial. A total of 42 patients with postherpetic neuralgia will be recruited and randomly divided into the intervention group and the control group. The control group will receive routine treatment plus oxygen, and the intervention group will receive routine treatment plus nitrous oxide/oxygen mixture. Data collectors, patients, and clinicians are all blind to the therapy. The outcomes of each group will be monitored at baseline (T0), 5 min (T1), and 15 min (T2) after the start of the therapy and at 5 min after the end of the therapy (T3). The primary outcome measure will be the pain intensity. Secondary outcomes included physiological parameters, adverse effects, patients’ acceptance of analgesia, and satisfaction from patients. Discussion Previous studies have shown that nitrous oxide/oxygen mixture can effectively relieve cancer patients with breakthrough pain. This study will explore the analgesic effect of oxide/oxygen mixture on PHN. If beneficial to patients with PHN, it will contribute to the pain management of PHN. Trial registration Chinese Clinical Trial Register ChiCTR1900023730. Registered on 9 June 2019

scholarly journals Premixed nitrous oxide/oxygen as an analgesic for dressing in patients with perianal abscess after surgery: study protocol for a randomized, within-patient, controlled trial

2019 ◽  
Author(s):  
Jun-Jun Zhang ◽  
Hai-Xiang Gao ◽  
Ting-Ting Zhang ◽  
Wen-Qiang Bao ◽  
Jian-Ying Mou ◽  
...  
Keyword(s):  
Nitrous Oxide ◽  
Pain Treatment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perianal Abscess ◽  
Oxygen Mixture ◽  
Control Group ◽  
Double Blind ◽  
Nitrous Oxide Oxygen ◽  
Dressing Change

Abstract Background:Perianal abscess is mainly treated by surgery in the clinic. However, the pain induced by dressing is the most prominent problem in postoperative patients and available analgesics is limited. The short- acting analgesia, premixed nitrous oxide/ oxygen, may be an ideal analgesic for acute pain induced by dressing change after perianal abscess surgery. This study aims to evaluate the safety and analgesic efficacy of premixed nitrous oxide/oxygen mixture for patients with dressing change after surgery around the anus. Methods/design:This protocol for a randomized, double-blind, placebo- controlled trial will be implemented in the Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University. Study subjects are hospitalized patients underwent perianal abscess surgery and suffered from moderate to severe pain due to dressing. Two hundred subjects will be selected and randomly assigned to other intervention or control group. The intervention group will get regular pain treatment plus premixed nitrous oxide/oxygen and the control group will be treated with regular pain treatment plus oxygen. The patients, medical staffs or investigators are blinded to the nature of the gas mixture in each cylinder and the randomization list. Data will be collected at baseline (T0, 2 min before dressing) and at 5 min (T1) after the beginning of intervention and at 5 min (T2) past dressing. The primary outcome will be the change in pain score at T1 and T2. Secondary outcomes cover physiological parameters, adverse events, patients and medical staffs’ satisfaction as well as patients’ acceptance. Discussion:The findings of this trial will provide a valuable therapeutic regimen for pain caused by dressing after perianal abscess surgery and identify the efficacy and safety of the gas.

Acupuncture (superficial dry-needling) as a treatment for chronic postherpetic neuralgia – a randomized clinical trial

2021 ◽  
pp. 204946372110230
Author(s):  
Martin Sollie ◽  
Robert Pind ◽  
Christoffer Bing Madsen ◽  
Jens Ahm Sørensen
Keyword(s):  
Clinical Trial ◽  
Neuropathic Pain ◽  
Randomized Clinical Trial ◽  
Postherpetic Neuralgia ◽  
Short Form ◽  
Intervention Group ◽  
Sham Acupuncture ◽  
Control Group ◽  
Dry Needling ◽  
Painful Condition

Background: Postherpetic neuralgia is a painful condition where finding sufficient treatment poses a great challenge. Acupuncture is often used as an alternative treatment for these pains, yet no randomized trials, using a sham-placebo have been performed to confirm its effect. Our objective was to investigate the efficacy of acupuncture compared to sham-acupuncture when treating chronic postherpetic dermal pain. Methods: We performed a sham-controlled double-blinded randomized clinical trial (RCT) with two arms. The intervention group received superficial dry-needling, and the control group received sham acupuncture using blunted needles. Twenty-six patients received two treatments. They filled out questionnaires at baseline and 1 month after treatment: (1) average and maximum pain (Numeric Rating Scale), (2) neuropathic pain (Neuropathic Pain Scale Inventory) and (3) Quality of Life (QoL) (Short-form 36). Results: Thirteen patients were allocated to the intervention group and 15 to the control group. We did not detect any significant changes in levels of pain and neuropathic pain. One QoL parameter, regarding emotional problems, reached a level of statistical significance. The sham-blinding was successful. This is the first RCT on the effect of acupuncture (superficial dry-needling) on postherpetic neuralgia (PHN), using a sham procedure as control. We observed no significant changes or tendencies in the measured levels of pain. One QoL parameter had significant improvement in the intervention group compared to the control group. Conclusion: In conclusion, acupuncture was not superior to treatment with sham acupuncture. Though individual patients may experience some pain relief from acupuncture, our results do not support the routine use of this type of acupuncture to treat PHN.

Nitrous oxide/oxygen inhalation provides effective analgesia during the administration of tumescent local anaesthesia for endovenous laser ablation

VASA ◽  
2015 ◽  
Vol 44 (6) ◽  
pp. 473-478 ◽  
Author(s):  
Thomas Oleg Meier ◽  
Vincenzo Jacomella ◽  
Robert Karl Josef Clemens ◽  
Beatrice Amann-Vesti
Keyword(s):  
Nitrous Oxide ◽  
Laser Ablation ◽  
Oxygen Mixture ◽  
Control Group ◽  
Endovenous Laser Ablation ◽  
Oxygen Inhalation ◽  
Nitrous Oxide Oxygen ◽  
Lower Pain ◽  
Endovenous Thermal Ablation ◽  
Lower Pain Score

Abstract. Background: Tumescent anaesthesia (TA) is an important but sometimes very painful step during endovenous thermal ablation of incompetent veins. The aim of this study was to examine whether the use of fixed 50% nitrous oxide/oxygen mixture (N2O/O2), also called equimolar mixture of oxygen and nitrous oxide, reduces pain during the application of TA. Patients and methods: Patients undergoing endovenous laser ablation (EVLA) of incompetent saphenous veins were included. Thirty consecutive patients inhaled N2O/O2 during the application of TA. Thirty consecutive patients received TA alone (controls). Patients were asked to complete a questionnaire immediately after the intervention to assess satisfaction with the intervention and pain-levels during the different steps of the intervention (0 = not at all, 10 = very much). Adverse events during the treatment were monitored. Results: 30 patients (14 men, mean age of 44 years) were included in the N2O/O2 group and 30 patients (9 men, mean age 48 years) were included in the control group. In the N2O/O2 group a significantly lower pain score was noted (mean 2.45 points, range 0 - 6) compared to the controls (mean 4.3 points, range 1 - 9, p < 0.001). Overall, 64.5 % of the patients were perfectly satisfied with the N2O/O2-Inhalation. Only 4 patients receiving N2O/O2 complained of adverse effects such as unpleasant loss of control (2 patients), headache (1 patient) and dizziness (1 patient). Conclusions: N2O/O2 is a safe and effective method to reduce pain during the application of tumescent anaesthesia for EVLA.

scholarly journals Comparing the Effects of Aloe Vera Ointment with Routine Treatment on the Severity of Diaper Dermatitis: A Randomized Controlled Double-Blinded Clinical Trial

2020 ◽  
Vol 9 (4) ◽  
pp. 158-162
Author(s):  
Shiva Heidari ◽  
Naser Parizad ◽  
Fatemeh Shirazi ◽  
Vahid Alinejad ◽  
Sima Ghanipour Badelbuu
Keyword(s):  
Clinical Trial ◽  
Therapeutic Option ◽  
Intervention Group ◽  
Aloe Vera ◽  
Control Group ◽  
Diaper Dermatitis ◽  
Herbal Products ◽  
Routine Treatment ◽  
Significant Difference ◽  
Double Blinded

Background: Diaper dermatitis (DD) is a prevalent skin disease in children, which causes child discomfort and parental concern. This study aimed to compare the effects of aloe vera ointment with routine treatment on the severity of DD in hospitalized children. Materials and Methods: This double-blinded randomized clinical trial was carried out on 60 children aged less than two years admitted to Tabriz pediatric hospital in Iran from February to June 2017. Using convenience sampling method, the patients were assigned into two equal groups (n=30 in each) of intervention and control. The intervention group received routine combination treatment, whereas the control group received aloe vera ointment. The patients were examined on the first, third, and sixth days of the study. Data analysis was performed using SPSS software (version 22) and descriptive and analytical statistics. Results: The severity of DD in both groups improved on the sixth day compared to the first day. In comparison, no significant difference was observed between the two groups regarding the severity of dermatitis (P>0.05). Conclusion: Herbal products cause fewer side effects than chemical products and seem to have significant pharmacological effects on the skin. Thus, aloe vera ointment appears to help treat DD and, with further studies, may emerge as a possible therapeutic option.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

Sign in / Sign up

Export Citation Format

Share Document