Comparing the efficacy and safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for sedation in colonoscopy patients: A double-blinded randomized clinical trial

Background: In this double-blinded randomized clinical trial, we aimed to compare the safety and efficacy of a combination of dexmedetomidine and ketamine [DK] with propofol and fentanyl [PF] for sedation in colonoscopy patients. Methods: In this study, 64 patients who underwent colonoscopy were randomized into two groups: 1) A, which received PF, and 2) B, which received DK for sedation. Among 64 patients, 31 patients were included in PF, and 33 patients were included in the DK group. Both groups were similar in terms of demographics. Patients’ sedation score (based on Ramsay sedation scale) and vital signs were recorded at 2, 5, 10, and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea, and vomiting, along with gastroenterologist satisfaction and patients’ pain score (based on Wong-Baker faces pain assessment scale), were recorded by a checklist. Data were analyzed by SPSS v.18 software, using chi-square, independent t-tests, and repeated measures analysis with p<0.05 as the criterion for significant differences. Results: The mean score of sedation was 4.82±0.49 in the DK group and 5.22±0.45 in the PF group [p value=0.001]. Serious complications, including hypotension [p value=0.005] and apnea [p value=0.10] were significantly higher in the PF group. Satisfaction of gastroenterologist [p value= 0.400] and patients’ pain score [p value = 0.900] were similar among groups. Conclusion: Combination of DK provides sufficient sedation with fewer complications in comparison with PF in colonoscopy patients.

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Comparing the efficacy and safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for sedation in colonoscopy patients: A double-blinded randomized clinical trial

10.21203/rs.3.rs-152368/v1 ◽

2021 ◽

Author(s):

Reza Aminnejad ◽

Ahmad Hormati ◽

Hamed Shafiee ◽

Faezeh Alemi ◽

Maryam Hormati ◽

...

Keyword(s):

Clinical Trial ◽

Pain Score ◽

Randomized Clinical Trial ◽

Vital Signs ◽

Repeated Measure ◽

P Value ◽

Chi Square ◽

Measure Analysis ◽

The Times ◽

Double Blinded

Abstract BackgroundIn this double-blinded randomized clinical trial, we aimed to compare safety and efficacy of combination of dexmedetomidine and ketamine (DK) with propofol and fentanyl (PF) for sedation in colonoscopy patients.MethodsIn this study, 64 patients undergoing colonoscopy were randomized in two groups, A, receiving PF, and B receiving DK for sedation. Among 64 patients, 31 patients included in PF and 33 patients included in DK group. Both groups were similar in terms of demographics. Patients’ sedation score (based on Ramsy scale) and vital signs recorded at the times of 2, 5, 10 and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea and vomiting along with gastroenterologist satisfaction and patients’ pain score (based on Wong Baker faces pain assessment scale) recorded by a checklist. Data were analyzed by SPSS V.18, using chi-square, independent t-tests and repeated measure analysis with a p value < 0.05 significance level.ResultsThe mean score of sedation was 4.82 ± 0.49 in DK group and 5.22 ± 0.45 in PF group (p value = 0.001). Serious complications, including hypotension (p value = 0.005) and apnea (p value = 0.10) were significantly higher in PF group. Satisfaction of gastroenterologist (p value = 0.400) and patients’ pain score (p value = 0.900) were similar among groups.ConclusionCombination of DK provides sufficient sedation with less complications in compare with PF in colonoscopy patients.Trial registrationThe study protocol designed on the basis of Helsinki declaration for ethical consideration and was approved by the Ethics Committee of Qom University of Medical Sciences (ethics code: IR.MUQ.REC.1397.149); the study was also registered at the Iranian Center for Clinical Trials (No. IRCT20161205031252N11).

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Comparison of Efficacy and Side Effects of Azithromycin and Co-Amoxiclav in the Treatment of Acute Sinusitis in Adults: A Randomized Clinical Trial

Global Journal of Health Science ◽

10.5539/gjhs.v8n11p178 ◽

2016 ◽

Vol 8 (11) ◽

pp. 178

Author(s):

Soroush Amani ◽

Ali Mohammadi-Najafabadi ◽

Ali Ahmadi

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Acute Sinusitis ◽

Chi Square ◽

Significant Difference ◽

Group 2 ◽

Double Blinded ◽

Minor Criteria

BACKGROUND: Regarding high prevalence of common cold and sinusitis in Chaharmahal and Bakhtiari Province and the lack of studies on patients referring hospitals in this province, this study was conducted to determine and compare the efficacy and side effects of azithromycin and co-amoxiclav.METHODS: This study was a double-blinded randomized clinical trial. The study population of this clinical trial was consisted of 90 patients with acute sinusitis aged 12-65 years. At least two major criteria or one major criterion and two minor criteria with duration of at least 7 days and at most 28 days, were some of the sinusitis diagnostic criteria for inclusion of the patients into the study. The patients were examined for symptoms prior to and twice after the treatment. The treatment was administration with 500 mg azithromycin tablet per day for three days in group 1 (G1) and 625 mg co-amoxiclav tablet every 8 h for 10 days in group 2 (G2). The data were analyzed by repeated measures analysis of variance, independent t-test, and chi-square in Stata software and P < 0.05 was considered significant.RESULTS: Mean±Standard deviation age of all patients was 32.14±9.91 years. Out of 90 participants in the study, 50 (55.56%) were male and the rest were female. The patients’ symptoms were quantitatively similar in the two groups (22.3±2 and 22.2±1.9 in G1 and G2, respectively) prior to the intervention. The score at second examination decreased to 3.7±2.1 in G1 and to 9.4±2.7 in G2, significantly different from that prior to intervention and between the two groups (P<0.001). Although the score decreased in the two groups at third examination, it was not significant in the two groups (P=0.652). The cure rate in azithromycin group was derived 87.5% and 88%, and in co-amoxiclav group 32.4% and 83.3% at the days 5 and 10 of treatment, respectively. The most prevalent side effects in the two groups were diarrhea and nausea. The prevalence of diarrhea was obtained 21% and 33% in G1 and G2, respectively. CONCLUSION: No significant difference in side effects was seen between the two groups. Although the cure was faster in the patients treated with azithromycin than those treated with co-amoxiclav, co-amoxiclav is still considered as adequately working against acute sinusitis bacterial pathogens. In view of this efficacy, co-amoxiclav seems to lead to no drug resistance and could be used to treat the patient

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Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial

The Angle Orthodontist ◽

10.2319/072115-492.1 ◽

2015 ◽

Vol 86 (4) ◽

pp. 625-630 ◽

Cited By ~ 20

Author(s):

Wendy D. Lobre ◽

Brent J. Callegari ◽

Gary Gardner ◽

Curtis M. Marsh ◽

Anneke C. Bush ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Pain Perception ◽

Control Group ◽

Eligibility Criteria ◽

Pain Scores ◽

Parallel Group ◽

Repeated Measures Analysis ◽

The Relationship

ABSTRACT Objective: To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. Materials and Methods: This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n = 29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α = .05. Results: During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P = .002) and biting pain (P = .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. Conclusion: The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

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Effect of Foot Reflexology on Postoperative Pain in Patients Undergoing Tibia Plating Surgery: A Randomized Clinical Trial

Complementary Medicine Journal ◽

10.32598/cmja.10.3.1019.1 ◽

2020 ◽

Vol 10 (3) ◽

pp. 258-269

Author(s):

Fatemeh Imani ◽

◽

Ebrahim Nasiri ◽

Houshang Akbari ◽

Mohammad Reza Safdari ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

Chi Square ◽

Chi Square Test ◽

And Control

Objective: One of the major problems of patients after orthopedic surgeries is acute pain. The present study aims to evaluate the effect of foot reflexology massage on postoperative pain in patients undergoing plating surgery for tibia fracture. Methods: This study is a randomized clinical trial conducted on 96 patients who were candidates for tibia plating surgery referred to Imam Ali Hospital in Bojnourd, Iran, randomly divided into intervention and control groups. Foot reflexology massage in the intervention group was performed on patients’ healthy feet for 10 minutes, one hour before surgery. In the control group, the foot sole was touched for one minute without any pressure. Pain intensity was measured using the standard Visual Analog Scale before and immediately after the intervention and 2, 4, 6, 12 and 24 hours after surgery. Data were analyzed using chi-square test, t-test, repeated measures ANOVA, Mann-Whitney U and Friedman tests. Results: The baseline pain scores in the intervention and control groups were reported 8.1±0.9 and 8.4±0.9, respectively. After the intervention, the pain score in these groups was reduced to 6.9±1.1 and 8.1±1.0, respectively (P<0.001). At other times, up to 24 hours after surgery, the pain reduction was higher in the intervention group (P<0.05). Conclusion: Foot reflexology massage reduces postoperative pain of patients undergoing tibia plating surgery. Therefore, this method can be used to reduce pain and anxiety in orthopedic surgery patients.

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The Effect of Paracetamol on the Patient-Controlled Pain After Coronary Artery Bypass Surgery: A Randomized Clinical Trial Study

Journal of Pharmaceutical Care ◽

10.18502/jpc.v9i4.8222 ◽

2022 ◽

Author(s):

Maziar Mahjoubifard ◽

Yalda Moeini ◽

Elham Feizabad ◽

Ali Abdolrazaghnejad

Keyword(s):

Clinical Trial ◽

Coronary Artery ◽

Pain Score ◽

Randomized Clinical Trial ◽

Coronary Artery Bypass ◽

Artery Bypass ◽

Bypass Graft ◽

P Value ◽

Double Blind ◽

The Mean

Background: Pain is one of the patients' common problems, and usual morbidity after coronary artery bypass graft (CABG). This study aimed to assess the effect of Paracetamol and fentanyl in reducing post-CABG pain. Methods: This double-blind randomized clinical trial was conducted on 160 patients undergoing elective CABG (80 in group F (Fentanyl) and 80 in group P (Paracetamol)), at the cardiac surgery department of hospitals affiliated with Zahedan University of Medical Sciences. In group F, 50μg of Fentanyl (intravenous (IV)) was injected followed by a solution of 10 μg/cc at a rate of 4 cc/hr. For patients in group P, 15 mg/kg of Paracetamol (IV) was administered followed by a solution of 25 μg/cc at a rate of 4 cc/hr. Patients have been infused with the named drugs within the first 24 hours after the operation. Pain severity was assessed by the visual pain score (VAS) tool at baseline, and two, four, eight, twelve, and twenty-four hours after the surgery. Results: The mean of pain score in 12 (P-value=0.002) and 24 (P-value<0.0001) hours after surgery in group P was significantly less than that of group F. The mean heart rate in patients receiving Paracetamol was significantly (P-value = 0.005) less than that of patients receiving Fentanyl for 4 hours after surgery. The mean of increasing creatinine postoperatively in two groups was significant. The mean of increasing AST and ALT postoperatively in group P was significant with no case of liver function impairment. Conclusion: It seems Paracetamol is a good choice for reducing post-CABG pain with no significant complication, although further and more comprehensive research is needed.

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Intravenous Bolus Fentanyl vs. Rectal Acetaminophen in Outcome and Quality of Anesthesia in Infants Undergoing Pyloromyotomy: A Randomized Clinical Trial

10.21203/rs.3.rs-26434/v1 ◽

2020 ◽

Author(s):

Behzad Aliakbari Sharabiani ◽

Daryosh Sheikhzadeh ◽

Sahar Akbari ◽

Nasim Arjmand ◽

Sina Parsay ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Preoperative Evaluation ◽

Hypertrophic Pyloric Stenosis ◽

Vital Signs ◽

Surgical Reconstruction ◽

Anesthesia Induction ◽

Time Duration ◽

Significant Difference ◽

Double Blinded

Abstract Background Hypertrophic Pyloric Stenosis (HPS) is one of the most common diseases requiring surgery in infants. Regardless of recruited surgical reconstruction techniques, preoperative evaluation, using proper anesthesia induction, perioperative, and postoperative care are the main determining factors in the outcome of these patients. This study aimed to evaluate and compare the premedication with intravenous fentanyl versus rectal acetaminophen on the anesthesia-related outcome of patients. Methods In this double-blinded randomized clinical trial, 24 infants who were managed to underwent a pyloromyotomy surgery due to the HPS were enrolled. Patients then randomly allocated into two groups of Fentanyl (F) or Acetaminophen (A). Anesthesia procedure was initiated with premedication with midazolam (0.03 mg/kg) co-administrated with fentanyl (1 µg/kg) in group F, and rectal acetaminophen (40 mg/kg) administrated 20 minutes prior to midazolam (0.03 mg/kg) in group A individuals. All patients’ vital signs, the period of each step of anesthesia, and the incidence of apnea were measured and recorded. Results Although the time duration from anesthesia termination till extubation and the recovery time were relatively shorter among the patients of the acetaminophen group, there were no statistically significant differences between the two groups. Patients in the acetaminophen group showed a lower level of pain in all evaluated timelines than those who were treated with fentanyl (p < 0.05). There was no statistically significant difference between the apnea incidence in two groups. Conclusion The use of rectal acetaminophen in infants who are planning to undergo pyloromyotomy due to HPS offers a better treatment outcome than fentanyl. Trial Registration: This study was approved by the Ethics Committee of Tabriz University of Medical Sciences under the registry code of IR.TBZMED.REC.1397.511. It was also registered in Iranian Registry of Clinical Trials (IRCT). The trial’s registration number (TRN) is IRCT20180726040601N1 ‘retrospectively registered’

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Comparision of two fluoride varnishes for controlling white spot lesions. Randomized clinical trial

REVISTA ODONTOLOGÍA PEDIÁTRICA ◽

10.33738/spo.v16i1.13 ◽

2017 ◽

Vol 16 (1) ◽

Author(s):

Jesús Alberto Luengo - Fereira

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

White Spot ◽

Controlled Clinical Trial ◽

White Spot Lesions ◽

Randomized Controlled Clinical Trial ◽

Chi Square ◽

Randomized Controlled ◽

Anterior Teeth ◽

The Mean

Objective: To compare two fluorinated varnishes for the control of white spot lesions.Material and Methods: A randomized controlled clinical trial was conducted. A total of 103 active whitespot lesions on permanent upper anterior teeth from 24 patients, aged 7 to 9 years were randomly assigned totwo groups, G1: Duraphat® (n=52) and G2: DuraShield® (n=51). Weekly applications were perform for fourconsecutive weeks. Fifth week the dimension, regression and activity of the lesions were evaluated. Student’sT test, Wilcoxon Ranks and Chi square were used at 5% significance. Results: At the end of the study, the lesion reduction was observed in 69.7%, finding significant differences(p<0.05) in the mean of the initial and final dimensions in general (2.74 mm to 1.91 mm) and in each group, G1(2.84 mm to 2.03 mm), G2 (2.64 mm to 1.78 mm). In the activity of the lesions, it was found in the G1, 12 active and6 inactive lesions; while in G2, there were 14 active and 29 inactive; these differences were significant (p<0.05). Conclusions: The two evaluated products showed similar clinical efficacy in the remineralization of activewhite spot lesions after 4 weeks of therapy.

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