Low-level laser therapy with 940 nm diode laser on stability of dental implants: a randomized controlled clinical trial

Low-level laser therapy (LLLT) is a non-invasive modality to promote osteoblastic activity and tissue healing. The aim of this study was to evaluate the efficacy of LLLT for improvement of dental implant stability. This randomized controlled clinical trial was performed on 80 dental implants placed in 19 patients. Implants were randomly divided into two groups (n = 40). Seven sessions of LLLT (940 nm diode laser) were scheduled for the test group implants during 2 weeks. Laser was irradiated to the buccal and palatal sides. The same procedure was performed for the control group implants with laser hand piece in “off” mode. Implant stability was measured by Osstell Mentor device in implant stability quotient (ISQ) value immediately after surgery and 10 days and 3, 6, and 12 weeks later. Repeated measures ANOVA was used to compare the mean ISQ values (implant stability) in the test and control groups. Statistical test revealed no significant difference in the mean values of implant stability between the test and control groups over time (P = 0.557). Although the mean values of implant stability changed significantly in both groups over time (P < 0.05). Although the trend of reduction in stability was slower in the laser group in the first weeks and increased from the 6th to 12th week, LLLT had no significant effect on dental implant stability.     

Prevention of rocuronium injection pain in paediatrics: Ketamine versus midazolam? A prospective randomized double blind study

Introduction

Rocuronium bromide is a non-depolarizing muscle relaxant related to mono-quaternary steroid group which is used commonly in general anaesthesia for the facilitation of endotracheal intubation and for maintenance of muscle relaxation. Rocuronium injection pain is a significant drawback with an incidence ranging from 50% to 80% [1] and [2]. Separation of children from their parents and shifting them to the OT is an everyday problem to paediatric anaesthetists, in our centre; majority of anaesthetists use IV midazolam to solve this problem, some anaesthetists use IV ketamine hydrochloride instead. This randomized, double-blind study was designed to compare the effect of IV ketamine versus IV midazolam in reducing rocuronium injection-related withdrawal movements in paediatric patients.

Methods

Hundred and twenty paediatric patients aged 2–10 years subjected to urologic procedures under general anaesthesia were randomly classified into two groups: the ketamine group in which IV ketamine 1 mg kg⁻¹ was given and the midazolam group in which IV midazolam 0.05 mg kg⁻¹ was given before shifting the child to the operation room.

Results

Ketamine showed a highly significant reduction in the incidence of rocuronium injection-related withdrawal movements in paediatric patients (P-value 0.000) compared to midazolam which was ineffective.

Conclusion

This study demonstrated that ketamine effectively reduced pain after injection of rocuronium in paediatric patients compared to midazolam which was ineffective, and both ketamine and midazolam resolved peacefully the problem of child-parent separation before shifting to the OR.     

Surgically performed rectus sheath block – Effect of morphine added to bupivacaine versus bupivacaine only: A prospective randomized controlled double blinded trial

BackgroundExtended abdominal midline incision in laparotomies is associated with severe postoperative pain that is impacted badly on all body systems; proper management of this pain is essential for patient comfort and to minimize these bad impacts. Bilateral rectus sheath block (BRSB) is an option to achieve this.Methods50 Adult patients classified ASA1 and ASA2 submitted to extended abdominal midline incision were included. Bilateral rectus sheath catheters (BRSCs) were placed surgically during abdominal closure for BRSB. Patients were randomly assigned into 2 groups: in group 1(morphine group); a mixture of bupivacaine and morphine was used for BRSB, while in group 2 (bupivacaine group), only bupivacaine was used for BRSB.ResultsThere was a significant reduction in visual analogue scale (VAS) at rest and mobilization in the morphine group compared to bupivacaine group during 6th, 12th and 18th postoperative hours with P values: 0.001, 0.007, 0.04 and 0.003, 0.006, 0.036 during the same periods, respectively.ConclusionAddition of morphine to local bupivacaine for BRSB was effective and safe technique to achieve good quality of postoperative analgesia in patients submitted to extended midline abdominal incision.     

A prospective, randomized, single-blind trial of 5-mm versus 3-mm ports for laparoscopic cholecystectomy: is smaller better?

Background

Single-incision laparoscopic cholecystectomy (SILC) is said to provide improved cosmesis with a reduction in postoperative pain, but SILC involves a change in operative technique. A single-blind, randomized controlled trial compared cosmetic outcomes and postoperative pain between 3- and 5-mm ports used for laparoscopic cholecystectomy (LC).

Methods

For this study, 80 patients with symptomatic gallstones were recruited from a single center and randomized to a LC using either a 5-mm port and three 3-mm ports (group A) or a 10-mm port and three 5-mm ports (group B). Operative details; pain scores at 1 h, 6 h, and 1 week; and analgesia required during the first week were collected. Cosmetic outcome was assessed at 6 months using a validated questionnaire.

Results

For each group, 40 patients were recruited. The two groups were well matched except for sex. Group A had 11 males, and Group B had 4 males. The mean operative time was 49 ± 12 min (range, 24–120 min) in the 3-mm group versus 46 ± 19 min (range, 21–124 min) in the control group (p = 0.40). The two groups did not differ statistically in the day case rate. The pain scores in Group A were 2.5 ± 2.1 at 1 h, 3.2 ± 2.2 at 6 h, and 0.8 ± 2.2 at 1 week versus 4.2 ± 2.9 at 1 h, 3.3 ± 2.4 at 6 h, and 2.1 ± 2.4 at 1 week in Group B (p = 0.003, 0.63, and 0.002, respectively). No difference in the analgesia consumption was observed during the first postoperative week. The patients in Group A had significantly better cosmetic outcome scores at 6 months.

Conclusion

The use of 3-mm ports is technically feasible in patients undergoing LC for gallstones. The operating times are comparable with those for conventional LC, whereas the pain scores are reduced, and the cosmetic outcome is better.     

Does sodium bicarbonate reduce painful voiding after flexible cystoscopy? A prospective,randomized, double‐blind,controlled trial

Study Type – Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Post‐cystoscopy dysuria occurs in 30–54% of patients but the exact mechanism of cause is unknown. The evidence for using sodium bicarbonate to alkalinize urine and alleviate post‐cystoscopy dysuria is at best circumstantial, taken from work with women with cystitis‐type symptoms. In a double‐blinded randomized design, this study documents a post‐cystoscopy dysuria rate of 28% with a mean pain score at 48 hours of 1.3 (scale 1–10). The effect of sodium bicarbonate compared to placebo did not show a significant reduction in incidence or level of post‐cystoscopy dysuria.

Objective

? To determine if sodium bicarbonate (Ural®) reduces painful voiding after flexible cystoscopy.

Patients and Methods

? 300 patients over 18 years old undergoing elective flexible cystoscopy were enrolled in a randomized, double‐blinded, placebo‐controlled trial. Patients with active urinary tract infections, indwelling urinary catheters and/or requiring additional procedures such as biopsy and dilatation were excluded. ? Painful voiding was quantified using a pain analogue scale from 0 to 10. Pre‐existing painful voiding, previous experience with Ural® and flexible cystoscopy were recorded. ? Flexible cystoscopy was performed to a standard protocol. Patients were randomised after recruitment to receive Ural® or placebo (glucose) powder four times a day for two days after the procedure. Trial outcome was assessed by estimating the change in pain incidence and severity from before to two days after by post‐procedural questionnaire.

Results

? Painful voiding was present in 84 of the 300 patients post flexible cystoscopy (45 of 160 patients receiving Ural®; 39 of 140 receiving placebo), but overall mean pain scores were low (1.25; standard deviation 2.4; on a 0–10 scale). ? Treatment with Ural® compared to placebo was associated with a non‐significant reduction in frequency of pain (28.9% vs 31.3%; incidence rate ratio 0.66; 95% CI 0.29–1.46; P = 0.30) and severity of pain (odds ratio 0.72; 95% CI 0.30–1.74; P = 0.47).

Conclusion

? In the replicable context of low post‐cystoscopy pain levels, we believe Ural® does not reduce painful voiding after flexible cystoscopy.     

Is bowel preparation before excretory urography necessary? A prospective, randomized, controlled trial

PURPOSE: A prospective, randomized, single blind, controlled trial was performed to determine whether routine bowel preparations are necessary for satisfactory visualization of the urinary system during IVP and compare the side effects of several bowel preparation methods. MATERIALS AND METHODS: A total of 200 patients between 17 and 70 years old at the outpatient department who were prescribed IVP were enrolled in this prospective study. Patients were divided into 4 groups and randomly received liquid supper, senna, magnesium sulfate solution and PEG-ELS as bowel preparation before IVP. Control and contrast images were assessed by a radiologist and a urologist blinded to the bowel preparation. IVP was given a visualization score, a fecal residue score, a bowel gas score and an overall quality score. Images were also divided into anatomical sections to assess visualization, and the effect of fecal residue and bowel gas. Questionnaires were prepared about the side effects of bowel preparation. RESULTS: For contrast images there was no significant difference in terms of visualization,, fecal residue, bowel gas and overall quality scores among the 4 groups. The same result was seen on the control image except for fecal residue scores, when the senna and PEG-ELS groups had a lower fecal residue score than the liquid supper group (p = 0.001). Interestingly when considering sectional images, the right renal region of the control image showed that the senna and PEG-ELS groups had better visualization scores with less bowel gas and fecal residue than the liquid supper only group. Patients in all 3 laxative bowel preparation groups except the liquid supper group reported side effects. There was no statistically significant difference among these 3 groups in the attitude toward ingesting laxatives again. CONCLUSIONS: Our results suggest that routine bowel preparation prior to IVP does not improve the visibility or overall quality of control or contrast images, while patients experience certain side effects due to the bowel preparation. The laxative bowel preparation may be helpful only when visualizing the right renal region on the control image.     

Lateral internal sphincterotomy versus 0.25 % isosorbide dinitrate ointment for chronic anal fissures: a prospective randomized controlled trial

Purpose

To compare the healing properties of lateral internal sphincterotomy (LIS) and isosorbide dinitrate (ISDN) ointment for chronic anal fissure.

Methods

Patients with a chronic anal fissure were randomly assigned to a group treated with ISDN ointment (n = 105) or a group treated with LIS (n = 102). The same investigators examined the patients in a blinded manner, 1, 2, 3, 6, and 12 months after the treatments.

Results

The anal fissure had healed completely by 4 weeks in 64.7 versus 92.2 %, and by 6 months in 77.1 versus 97.1 % of the ISDN and LIS group patients, respectively. At 12 months, the recurrence rates were 4.8 versus 1 % for the ISDN and LIS groups, respectively, and the success rates of the treatments were 72.4 versus 96.1 %, respectively. Six patients in the LIS group experienced minor fecal incontinence, and seven (6.7 %) patients in the ISDN group experienced headaches that responded well to paracetamol.

Conclusion

ISDN ointment was reported by all patients to be easy to use. Although its success rate was lower than that of surgery, ISDN can be offered to selected patients with a chronic anal fissure, as it has a low recurrence rate and rare side effects are rare.     

Is ureteral stenting necessary after uncomplicated ureteroscopic lithotripsy? A prospective, randomized controlled trial

PURPOSE: We conducted a prospective, randomized controlled study to investigate the advantages and disadvantages of ureteral stenting after ureteroscopic lithotripsy. MATERIALS AND METHODS: A total of 60 patients who underwent ureteroscopic lithotripsy were equally randomized into a stented or a nonstented group. The inclusion criteria were stone 6 to 10 mm., absence of polyp or stricture in the ureter and no mucosal injury during ureteroscopy. The operation was performed with a 6Fr rigid ureteroscope without ureteral dilation and stones were fragmented with a 1.9Fr electrohydraulic lithotriptor without extraction. A 7Fr double pigtail stent was placed in the stented group for 3 days after ureteroscopy. Urinalysis, plain x-ray and renosonography were performed before and after lithotripsy in each patient. Subjective symptoms and pain score were recorded on admission to the hospital and 3 days postoperatively. RESULTS: The stone-free rate was 100% in each group and preoperative hydronephrosis equally resolved in both groups. Mean pain score plus or minus standard deviation improved significantly in the nonstented (6.33 +/- 1.81 preoperatively to 2.30 +/- 1.93 postoperatively, paired Student's t test p <0.0001) and stented (7.10 +/- 1.03 to 2.30 +/- 2.22, p < 0.0001) group. There was no statistical difference in pain reduction between the 2 groups (p = 0.18). The amount of extra parenteral analgesic used was similar in both groups. One patient in the nonstented group visited the emergency room for postoperative renal colic, 25 (83.3%) patients in the stented group complained of at least 1 irritative bladder symptom and only 4 (13.3%) in the nonstented group experienced bladder discomfort. CONCLUSIONS: After uncomplicated ureteroscopic electrohydraulic lithotripsy patients without ureteral stenting tend to have similar renal function recovery and satisfactory pain reduction with less irritative symptoms compared to those treated with a ureteral stent. We suggest that it is not necessary to place a ureteral stent routinely after uncomplicated ureteroscopic electrohydraulic lithotripsy for stones smaller than 1 cm.     

Quality comparison of remote anesthetic consultation versus on-site consultation in children with sedation for a magnetic resonance imaging examination—A randomized controlled trial

Background

In the course of the corona pandemic, digital media has increasingly been used in many areas of medical practice to reduce personal contact. As it is of interest whether this can be practiced in the context of anesthesia consultations without loss of quality, we interviewed parents whose children received a cardiac or neuro magnetic resonance imaging (MRI) under sedation. Parents either received an on-site or a remote consultation conducted by an anesthesiologist. Both parents and anesthesiologist were asked to indicate their satisfaction with the respective consultation procedure in a questionnaire.

Aim

The aim of this study was to investigate if remote pre-anesthesia consultation, supported by an online video, for parents whose children are receiving MRI examinations under sedation can replace the commonly performed on-site consultation, without decreasing its quality.

Methods

In this randomized trial, a total of 200 patients were included, one half received pre-anesthesia consultation on-site and the other half was given a link to a video and pre-anesthesia consultation was conducted by phone. As a primary analysis, we compared the level of satisfaction for the general procedure, the quality of the pre-anesthesia consultation and the contact to the anesthesiologists (or parents). We further investigated the frequency of complications and the preference for a possible next informed consent.

Results

Both groups showed high levels of satisfaction. Some anesthesiologists and parents were less satisfied with the quality of on-site pre-anesthesia consultation than with the remote. In our patient cohort, there was no evidence for higher risk of complications when information was provided by telephone. Further, parents as well as anesthesiologists clearly favored the combined form of telephone information and online video. Overall, 61.2% of parents and 64% of anesthesiologists would choose this form of pre-anesthesia consultation for repeat anesthesia.

Conclusions

We did not observe that combined telephone and video decreased the quality of pre-anesthesia consultation. A remote version seems feasible for simple procedures such as sedation for MRI. Further research on this topic in other areas of anesthesia would be beneficial.     

Ex vivo and in vivo investigations of the novel 1,470 nm diode laser for potential treatment of benign prostatic enlargement

Perioperative haemorrhage is still the major complication of transurethral resection of the prostate (TURP) for benign enlargement of the prostate. Photoselective vaporisation of the prostate (PVP) with the potassium–titanyl–phosphate (KTP) laser has been shown to achieve instant tissue ablation with excellent haemostatic properties. Our aim was to determine the tissue removal capacity, coagulation and haemostatic property of the novel 1,470 nm diode laser, ex vivo and in vivo. We evaluated two prototype diode laser systems at 1,470 nm in an ex vivo, isolated, blood-perfused, porcine kidney model (n = 5; 10 W–50 W) and in an in vivo investigation of beagle prostate (n = 4; 100 W) to assess vaporisation capacities and coagulation properties at different generator settings. The diode laser evaluation was compared with an 80 W KTP laser in the porcine model. After the laser treatment we performed a histological examination to compare the depth of coagulation and vaporisation. The diode laser system (50 W) showed significantly lower (P < 0.0001) capacities for tissue removal than the 80 W KTP laser (0.96 mm ± 0.17 mm and 5.93 mm ± 0.25 mm, respectively, P < 0.0001), while coagulation zones were significantly (P < 0.001) larger in diode laser-treated kidneys (3,39 mm ± 0.93 mm and 1.27 mm ± 0.13 mm, respectively). In vivo, the diode laser displayed rapid ablation of prostatic tissue with no intraoperative haemorrhage. Histological examination revealed coagulation zones of 2.30 mm (±0.26) at 100 W in the diode laser-treated prostates.     

Combined conventional/antioxidant ＂Astaxanthin＂ treatment for male infertility： a double blind, randomized trial

Aim： To evaluate the treatment of male infertility with a strong natural antioxidant, in addition to conventional treatment. Methods： Using a double blind, randomized trial design, 30 men with infertility of ≥12 months and female partners with no demonstrable cause of infertility received conventional treatment according to the guidelines of the World Health Organization （WHO）, and either a strong antioxidant Astaxanthin 16 rag/day （AstaCarox, AstaReal AB, Gustavsberg, Sweden） or placebo for 3 months. The effects of treatment on semen parameters, reactive oxygen species （ROS）, zona-free hamster oocyte test, serum hormones including testosterone, luteinizing hormone （LH）, follicle stimulating hormone （FSH） and Inhibin B, and spontaneous or intrauterine insemination （IUI）-induced pregnancies were evaluated. Results： ROS and Inhibin B decreased significantly and sperm linear velocity increased in the Astaxanthin group （n = 11）, but not in the placebo group （n = 19）. The results of the zona-free hamster oocyte test tended to improve in the Astaxanthin group in contrast with the placebo group, though not reaching statistical significance. The total and per cycle pregnancy rates among the placebo cases （10.5 % and 3.6 %） were lower compared with 54.5 % and 23. 1% respectively in the Astaxanthin group （P=0.028; P=0.036）. Conclusion： Although the present study suggests a positive effect of Astaxanthin on sperm parameters and fertility, the results need to be confirmed in a larger trial before recommending Astaxanthin for the complementary treatment of infertile men. （Asian J Androl 2005 Sep; 7： 257-262）     

A prospective, randomized, double-blind comparison of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine for maxillary infiltrations

The purpose of this prospective, randomized, double-blind crossover study was to compare the anesthetic efficacy of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine in maxillary central incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary central incisor and first molar infiltrations of 1.8 mL of 2% mepivacaine with 1 : 20,000 levonordefrin and 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine at 2 separate appointments spaced at least 1 week apart. The teeth were electric pulp tested in 2-minute cycles for a total of 60 minutes. Anesthetic success (obtaining 2 consecutive 80 readings with the electric pulp tester within 10 minutes) was not significantly different between 2% mepivacaine with 1 : 20,000 levonordefrin and 2% lidocaine with 1 : 100,000 epinephrine for the central incisor and first molar. However, neither anesthetic agent provided an hour of pulpal anesthesia.     

Does the timing of tracheal intubation based on neuromuscular monitoring decrease laryngeal injury? A randomized, prospective, controlled trial

Vocal cord injuries (VCI) and postoperative hoarseness (PH) are common complications after general anesthesia. Poor muscle relaxation at the moment of tracheal intubation may result in VCI. There is a large interindividual variation in neuromuscular depression after administration of neuromuscular blocking drugs. Therefore, the optimal individual timing of tracheal intubation based on neuromuscular monitoring (monitoring) may decrease VCI. In this prospective trial, 60 patients were randomized into 2 groups: Monitoring group: tracheal intubation at maximum block based on monitoring after atracurium 0.5 mg/kg and 2-min group: tracheal intubation 2 min after injection of atracurium 0.5 mg/kg. Intubating conditions were evaluated with the Copenhagen score. VCI were examined by stroboscopy before and 24 and 72 h after surgery. PH was assessed at 24, 48, and 72 h after surgery by a standardized interview. Excellent intubating conditions were significantly increased in the monitoring group compared with the 2-min group: 8 versus 2 patients, respectively (P = 0.036). The incidence of PH between the study groups was comparable: 7 (monitoring) versus 8 patients (2-min) (P = 0.860). Similar findings were observed for VCI: 9 versus 5 patients; respectively (P = 0.268); type of VCI: thickening of the vocal cords: 8 (monitoring) versus 5 (2-min) patients (P = 0.423), hematomas: 2 patients in each group (not significant). The present study demonstrated that neuromuscular monitoring improved endotracheal intubating conditions. However, tracheal intubation at maximum intensity of neuromuscular block was not associated with a decrease in vocal cord injuries.     

Management of intraoperative hemorrhage during NOTES®: a prospective, randomized comparison

Background

The optimal strategy to manage intraoperative hemorrhage during NOTES^® is unknown. A randomized comparison of three instruments for hemorrhage control was performed [prototype endoscopic bipolar hemostasis forceps (BELA) vs. prototype endoscopic clip (E-CLIP) applier versus laparoscopic clip (L-CLIP) applier].

Methods

A hybrid transvaginal NOTES model in swine was used, with hemorrhage induced in either the gastroepiploic (GE) arteriovenous bundle (vessel diameter ~3 mm) or in distal mesenteric vessels (vessel diameter ~1–2 mm). Hemostasis was attempted three times per vessel using each instrument in a randomized order. Full laparoscopic salvage was performed if hemorrhage persisted beyond 10 min. Outcomes included primary success rate (PS), primary hemostasis time (PHT), number of device applications (DA), and overall hemostasis time (OHT, including salvage).

Results

Seventy hemostasis attempts were made in 12 swine. PS was 42–67 % for the GE vessels, with no difference between instruments. PHT and OHT also were similar between instruments, with the BELA and L-CLIP having a higher number of DA. PS was (80–100 %) in mesenteric vessels, with the BELA and L-CLIP resulting in a shorter mean PHT compared with the E-CLIP.

Conclusions

All three instruments had similar effectiveness in achieving primary hemostasis during hybrid NOTES. Management of small vessel bleeding (1–2 mm) in a porcine model is effective using all three instruments but may be most efficient with the BELA or L-CLIP. Large vessel bleeding (≥3 mm) may be best managed by adding laparoscopic ports for assistance while maintaining a low threshold for conversion to full laparoscopy.     

Postoperative catheterization after anterior colporrhaphy: 2 versus 5?days. A multicentre randomized controlled trial

Introduction and hypothesis  

The aim of this study was to compare the number of temporary catheter replacements and urinary tract infections after indwelling catheterization for 2 versus 5 days following an anterior colporrhaphy.