Tolerability of IM penicillin G benzathine diluted or not with local anesthetics, or different gauge needles for syphilis treatment: a randomized clinical trial

Abstract Background Penicillin G Benzathine (PGB) is the cornerstone of syphilis treatment. However, its intramuscular (IM) administration is associated with pain at the site of injection. The dilution of PGB with local anesthetics is recommended in some guidelines, but the evidence that supports it, particularly in adults and in HIV infection, is scarce. Preliminary clinical experience also suggests that the IM administration of PGB through increased needle gauges might improve its tolerability. The aim of the study to identify less painful ways of administering IM PGB in the treatment of syphilis in adults. Methods Multicenter, randomized, double-blinded clinical trial in patients diagnosed with primary syphilis that required a single IM injection of PGB 2400,00 IU. Patients were randomized to receive PGB diluted with 0.5 mL mepivacaine 1% (MV) or PGB alone, and both groups either with a long 19G or short 21G IM needle. The primary objective was the effect on local pain immediately after the administration through a visual scale questionnaire on pain (0 to 10). Results One hundred eight patients were included, 27 in each group. Ninety-four (94.4%) were male, and 41.7% were also HIV-infected. Mean age 36.6 years (SD 11). Significant differences in immediate pain intensity were observed when comparing the long 19G group with anesthesia (mean pain intensity, [MPI] 2.92 [CI 95% 1.08-4.07]) vs long 19G without anesthesia (MPI 5.56 [CI 95% 4.39-6.73), p < 0.001; and also between short 21G group with anesthesia (MPI 3.36 [CI 95% 2.22-4.50]) vs short 21G without anesthesia (MPI 5.06 [CI 95% 3.93-6.19]), p = 0.015). No significant differences in immediate pain were observed between 19G and 21G in the presence or absence of anesthesia (p = 1.0 in both cases). No differences were found between study arms after 6 and 24 h. Conclusions The IM administration of 1% mepivacaine-diluted PGB induces significantly less immediate local pain as compared to PGB alone. The needle gauge did not have any effect on the pain. Based on these results, we suggest anesthetic-diluted IM PGB as the standard treatment for primary syphilis. Trial registration EudraCT 2014-003969-24 (Date of registration 18/09/2014).

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Pain intensity and cervical range of motion in women with myofascial pain treated with acupuncture and electroacupuncture: a double-blinded, randomized clinical trial

Brazilian Journal of Physical Therapy ◽

10.1590/bjpt-rbf.2014.0066 ◽

2015 ◽

Vol 19 (1) ◽

pp. 34-43 ◽

Cited By ~ 18

Author(s):

Maria F. M. Aranha ◽

Cristina E. E. Müller ◽

Maria B. D. Gavião

Keyword(s):

Clinical Trial ◽

Pain Intensity ◽

Range Of Motion ◽

Randomized Clinical Trial ◽

Myofascial Pain ◽

Cervical Range Of Motion ◽

Double Blinded

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The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain after Laparoscopic Varicocelectomy: A Randomized Controlled Trial

Children ◽

10.3390/children8111051 ◽

2021 ◽

Vol 8 (11) ◽

pp. 1051

Author(s):

Zenon Pogorelić ◽

Tea Gaberc ◽

Miro Jukić ◽

Goran Tintor ◽

Ana Nevešćanin Biliškov ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Pain Intensity ◽

Randomized Clinical Trial ◽

Local Anesthetic ◽

Local Anesthetics ◽

Control Group ◽

Number Of Patients ◽

Intraperitoneal Instillation ◽

Time Point

Background: The main goal of the present randomized clinical trial was to investigate the effects of subcutaneous administration of two different local anesthetics at trocar incision sites at the abdominal wall in combination with intraoperative intraperitoneal instillation of local anesthetics, on the character of postoperative pain, in adolescents who underwent laparoscopic varicocelectomy. Methods: A total of 60 patients with a median age of 16 years, who received laparoscopic varicocele repair, were included in this randomized clinical trial. The patients were randomly assigned to three study groups receiving 2% lidocaine, 0.5% levobupivacaine, or the control group. The Visual Analogue Scale (VAS) was used by a blinded nurse at four different time points (2, 6, 12 and 24 h after the surgery) to measure pain intensity. Results: The significant effect of time on the pain intensity (p = 0.001) was found. Additionally, the interaction between time and different local analgesics (p < 0.001) was observed. In patients in whom 0.5% levobupivacaine has been used, significantly lower VAS pain scores were recorded at each time point assessed, in comparison with the patients who received 2% lidocaine or the patients from the control group in whom no local anesthetic was applied (p < 0.001). Furthermore, in patients in whom 2% lidocaine was administrated, significantly lower pain levels according to VAS were reported than in those from the control group, except for the time point at 24 h after surgery when pain levels were comparable. Concerning the postoperative pain control, the number of patients who requested oral analgesics postoperatively was significantly lower in the group of patients in whom local anesthetic was administrated intraoperatively (2% lidocaine – n = 4, 20%; 0.5% levobupivacaine – n = 1, 5%) compared to the patients who did not receive any local anesthetic during the surgery (n = 13; 65%) (p < 0.001). Conclusion: A significant reduction in postoperative pain intensity and analgesics consumption in patients undergoing laparoscopic varicocelectomy who received intraoperative local anesthetic was observed. The best effect on postoperative pain intensity, according to the VAS score, was achieved by 0.5% levobupivacaine.

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Dose effect of local anesthetics on analgesic outcomes for the transversus abdominis plane (TAP) block in children: a randomized, double-blinded, clinical trial

Pediatric Anesthesia ◽

10.1111/pan.12550 ◽

2014 ◽

Vol 25 (5) ◽

pp. 506-510 ◽

Cited By ~ 16

Author(s):

Santhanam Suresh ◽

Lauren J. Taylor ◽

Gildasio S. De Oliveira

Keyword(s):

Clinical Trial ◽

Local Anesthetics ◽

Transversus Abdominis ◽

Dose Effect ◽

Tap Block ◽

Transversus Abdominis Plane ◽

Double Blinded

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Evaluation of penicillin G potassium troches in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and no-treatment–controlled, multicenter clinical trial

Oral Surgery Oral Medicine Oral Pathology Oral Radiology and Endodontology ◽

10.1016/j.tripleo.2009.11.006 ◽

2010 ◽

Vol 109 (4) ◽

pp. 561-566 ◽

Cited By ~ 8

Author(s):

Yu Zhou ◽

Qiaming Chen ◽

Wenxia Meng ◽

Lu Jiang ◽

Zhi Wang ◽

...

Keyword(s):

Clinical Trial ◽

Penicillin G ◽

Multicenter Clinical Trial ◽

Chinese Cohort ◽

Aphthous Ulceration ◽

Double Blinded ◽

Recurrent Aphthous Ulceration

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A bioequivalence study of proposed bevacizumab biosimilar, MYL-1402O (A) vs EU-Avastin (B) and US-Avastin (C).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e14034 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e14034-e14034 ◽

Cited By ~ 1

Author(s):

Mark A. Socinski ◽

Matthew Hummel ◽

Tjerk Bosje ◽

Andrew Shaw ◽

Mark Shiyao Liu ◽

...

Keyword(s):

Clinical Trial ◽

Healthy Adult ◽

Bioequivalence Study ◽

Primary Objective ◽

Double Blind ◽

Safety Issues ◽

Parallel Group ◽

Healthy Adult Male ◽

To Receive ◽

Clinical Trial Information

e14034 Background: MYL-1402O is a proposed bevacizumab biosimilar. The similarity of MYL-1402O to Avastin has been demonstrated in physicochemical analyses, and nonclinical studies. Methods: This single-center, randomized, double blind, three-arm, parallel-group, study was conducted in healthy adult male volunteers. The primary objective of this study was to establish PK similarity of A to B and C, and B to C. Subjects were randomized to receive either A, B or C 1 mg/kg over 90 minutes as an intravenous infusion. Dose was selected based on the lower dose in the linear range of PK and acceptable safety in healthy volunteers. Bioequivalence was to be concluded if the 90% CIs of the ratios (A/B, A/C and B/C) of LS means of the natural log transformed AUC0-inf were within 80% to 125%. AUC0-t, Cmax, tmax, kel and t½ were assessed as secondary PK parameters. Results: A total of 111 subjects (37/treatment) were enrolled and 110 [37 (A), 36 (B), 37(C)] were included in the analysis. Bioequivalence was demonstrated between A and B, A and C and between B and C. LS mean ratios were close to 1, and 90% CIs were within 0.80 to 1.25 for all of the comparisons. The secondary PK parameters were also comparable with the 90% CIs for ratios of AUC0-t and Cmax within 80%-125%. A total of 313 TEAEs were reported, 116 by 33 (89%) subjects who received A, 99 by 29 (78%) subjects who received B and 98 by 28 (76%) subjects who received C. Most TEAEs were consistent with the clinical data of bevacizumab (Avastin). No serious or unexpected TEAEs were reported. TEAEs were grade 1 or grade 2 in severity. The anti-drug antibodies are being evaluated (pending results). Conclusions: These results confirm bioequivalence of Myl-1402O vs. EU-Avastin and US-Avastin. All treatments were well tolerated and no significant safety issues emerged. Clinical trial information: NCT02469987 Clinical trial information: NCT02469987.

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