Lidocaine Adrenaline Tetracaine Gel Versus Tetracaine Adrenaline Cocaine Gel for Topical Anesthesia in Linear Scalp and Facial Lacerations in Children Aged 5 to 17 Years

PEDIATRICS ◽  
1995 ◽  
Vol 95 (2) ◽  
pp. 255-258 ◽  
Author(s):  
Amy A Ernst ◽  
Eduardo Marvez ◽  
Todd G. Nick ◽  
Eric Chin ◽  
Edmond Wood ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Inner City ◽  
Rating Scale ◽  
Topical Anesthesia ◽  
Random Numbers ◽  
Study Objective ◽  
The Face ◽  
Double Blinded

Study objective. The purpose of the present study is to compare LAT gel (4% lidocaine, 1:2000 adrenaline, 0.5% tetracaine) to TAC gel (0.5% tetracaine, 1:2000 adrenaline, 11.8% cocaine) for efficacy, side effects, and costs in children aged 5 to 17 years with facial or scalp lacerations. Design. Randomized, prospective, double-blinded clinical trial. Setting. Inner-city Emergency Department with an Emergency Medicine residency program. Patients or other participants. Children aged 5 to 17 years with linear lacerations of the face or scalp. Intervention. After informed consent was obtained patients had lacerations anesthetized with topical TAC or LAT gel according to a random numbers table. Measurements and main results. A total of 95 patients were included in the statistical analysis with 47 receiving TAC and 48 receiving LAT. Physicians and patients/parents separately rated the overall pain of suturing using a modified multidimensional scale for pain assessment specifically for children. Patients/parents also stated the number of sutures causing pain. The power of the study to determine a ranked sum difference of 15 was 0.8. Multidimensional rating scale results and number and percentage of sutures causing pain were compared using Wilcoxon's rank sum test. According to patients no difference could be detected in percent of sutures causing pain in the LAT versus TAC group (P = .51). Using the multidimensional scale, physicians and patients/parents found LAT statistically the same as TAC in effectiveness (P = .80 for physicians and P = .71 for patients). Cost per application was $3.00 for LAT compared to $35.00 for TAC. Follow-up was accomplished in 85 of 95 participants in the study with no reported complications for either medication. Conclusion. LAT gel worked as well as TAC gel for topical anesthesia in facial and scalp lacerations. Considering the advantages of a noncontrolled substance and less expense, LAT gel appears to be better suited than TAC gel for topical anesthesia in laceration repair in children.

The Efficacy of Propofol vs. Subcutaneous Sumatriptan for Treatment of Acute Migraine Headaches in the Emergency Department: A Double-Blinded Clinical Trial

Pain Practice ◽  
2014 ◽  
Vol 15 (8) ◽  
pp. 701-705 ◽  
Author(s):  
Hossein Moshtaghion ◽  
Najmeh Heiranizadeh ◽  
Abolghasem Rahimdel ◽  
Alireza Esmaeili ◽  
Hamidreza Hashemian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Acute Migraine ◽  
Migraine Headaches ◽  
Subcutaneous Sumatriptan ◽  
Double Blinded

scholarly journals Intravenous Paracetamol vs Intranasal Desmopressin for Renal Colic in the Emergency Department: A Randomized Clinical Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3437-3442
Author(s):  
Hamed Basir Ghafouri ◽  
Niloofar Abazarian ◽  
Mohammadreza Yasinzadeh ◽  
Ehsan Modirian
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Pain Score ◽  
Randomized Clinical Trial ◽  
Renal Colic ◽  
Rating Scale ◽  
Pain Scores ◽  
Intravenous Paracetamol ◽  
Significant Difference ◽  
Intranasal Desmopressin

Abstract Objective To evaluate the analgesic efficacy of intranasal desmopressin alone vs intravenous paracetamol in patients referred to the emergency department with renal colic. Design Randomized clinical trial. Setting This study was conducted in the emergency unit of a university hospital. Subjects Patients referred to the emergency room with renal colic. Primary Outcome Effect of intranasal desmopressin in pain relief in comparison with intravenous paracetamol. Methods In this trial, 240 patients diagnosed with renal colic were randomly divided into two groups to compare the analgesic effect of intravenous paracetamol (15 mg/kg) and intranasal desmopressin spray (40 μg). Pain scores were measured by a numeric rating scale at baseline and after 15, 30, and 60 minutes. Adverse effects and need for rescue analgesic (0.05 mg/kg max 3 mg morphine sulphate) were also recorded at the end of the study. Results Three hundred patients were eligible for the study; however, 240 were included in the final analysis. The patients in the two groups were similar in their baseline characteristics and baseline pain scores. The mean pain score after 15 minutes was more reduced and was clinically significant (>3) in the desmopressin group (P < 0.0001). There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6). Conclusions Our study showed that intranasal desmopressin is as effective as intravenous paracetamol for renal colic pain management; however, significant clinical reduction in pain score occurred faster with intranasal desmopressin.

Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS7087-TPS7087
Author(s):  
Douglas W. Blayney ◽  
Lan Huang ◽  
Ramon W. Mohanlal
Keyword(s):  
Clinical Trial ◽  
Small Molecule ◽  
Bone Pain ◽  
Rating Scale ◽  
Single Agent ◽  
Lung Lesion ◽  
Severe Neutropenia ◽  
Fixed Dose ◽  
Eortc Qlq ◽  
Double Blinded

TPS7087 Background: Plinabulin (Plin) is a small molecule with anti-cancer activity and CIN effects. The Phase (Ph) 2 clinical trial NPI-2358-101 ( NCT00630110 ) evaluated Plin at 20 or 30 mg/m2 on Day (D) 1 and D8) plus D1 Docetaxel (Doc) 75 mg/m2 combination versus D1 Doc alone in patients (pts) with non-small cell lung cancer(NSCLC). In a large ( > 70%) subset of pts with a measurable lung lesion in the lung (per RECIST 1.1) receiving 30 mg/m2 Plin + Doc (n = 38), mOS was 4.6 months longer vs Doc alone (n = 38) (Mohanlal ASCO-SITC 2018). An unexpected post-hoc finding was a CIN benefit with adding at 20 or 30 mg/m2 Plin to Doc: 33% of pts in the Doc arm had grade 4 neutropenia, whereas in the Plin +Doc group 4% of pts (P < 0.0003) (Blayney ASH 2018). Plin boost the number the number of hematopoietic/progenitor cells in bone marrow. We subsequently initiated two global Ph3 programs with Plin: 1. A Ph 3 trial confirming its anticancer activity in NSCLC (study BPI-2358-103; NCT02504489; this trial is ongoing) and 2. An evaluation of Plin for CIN prevention through studies BPI-2358-105 (NCT03102606; PROTECTIVE-1), and study 106 (NCT03294577; PROTECTIVE-2). We previously reported from the Ph 2 portion of study 105, that SA Plin and Pegfigrastim (Peg) had comparable protection against CIN induced by Doc, however in contrast to Peg, Plin did not cause bone pain or thrombocytopenia (Blayney IASLC 2018, ESMO 2018). Plin is given by 30 min IV infusion on the same day of Chemo, 30 min after Chemo. The Ph3 portion of Study 105 in ongoing. Methods: In the Ph 3 portion of PROTECTIVE-1, pts with NSCLC, HRPC or BC are randomized (1:1) to either Plin 40 mg (over 30 minutes on D1; n = 75) or Peg 6mg (on D2, n = 75), and the primary endpoint is Duration of Severe Neutropenia (DSN). Plin 20 mg/m2 is similar to a 40 mg fixed dose. Absolute neutrophil counts (ANC) is determined on D 0, 1,2,3,6,8,9,10, 15 in Cycle 1 The trial aims to demonstrate non-inferiority of Plin vs Peg. Non-inferiority will be declared if the non-inferiority margin (NIM) of 0.65 day will be met, which NIM is more conservative than the 1 day NIM, typically employed for G-CSG biosimilar trials. Pts should have at least 1 risk factor as per NCCN guidelines.The trial is double-blinded to enable reliable PRO, Bone Pain and QoL assessments through validated questionnaires (EQ-5D-5L; EORTC QLQ-C30; Wang Baker Faces Pain Rating Scale). Following an Interim Analysis, the trial will continue without modifications. Clinical trial information: NCT03102606 .

scholarly journals Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Farahzad Janatmakan ◽  
Sara Jorairahmadi ◽  
Fatemeh Javaherforooshzadeh ◽  
Pooyan Alizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Disability Rating Scale ◽  
Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

Is Continuity of Care Preserved in Children Who Utilize the Pediatric Emergency Department?

PEDIATRICS ◽  
1995 ◽  
Vol 95 (1) ◽  
pp. 37-41
Author(s):  
Patrick M. Vivier ◽  
William J. Lewander ◽  
Stanley H. Block ◽  
Peter R. Simon ◽  
Anthony J. Alario ◽  
...  
Keyword(s):  
Primary Care ◽  
Emergency Department ◽  
Inner City ◽  
Health Center ◽  
Continuity Of Care ◽  
Pediatric Emergency ◽  
Health Centers ◽  
Pediatric Emergency Department ◽  
Primary Care Site

Objective. Inner city families often use multiple sites for nonemergent medical care, including the pediatric emergency department. This practice raises concerns about continuity of care. The present study examined one aspect of continuity of care: Do children who receive care in a pediatric emergency department return to their primary care site so that appropriate follow up may be obtained? Methods. Over a 4-week period two groups of neighborhood health center children were studied: Those who sought care at the pediatric emergency department and those who were "walk-ins" at the health centers. All visits during the 4-week study period which resulted in a recommendation for the child to be seen within 6 weeks at the health centers were included in the analysis. Results. During the study period there were 87 patient visits to the pediatric emergency department with a documented physician instruction to be seen at their health center within 6 weeks. In 66 (76%) of the cases, the patient was seen at one of the health centers during the 6 weeks following the pediatric emergency department visit. There were 146 "walk-in" visits to the health centers with a documented physician instruction to be seen again at the health centers during the 6 weeks following the walk-in visit. In 111 (76%) of the cases, the patient was seen during the 6-week period. Conclusion. Our study shows that revisit rates were comparable for the two groups. We conclude that the rate of compliance with follow-up recommendations is similar for those who utilized the pediatric emergency department versus those who used the primary care site.

scholarly journals Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial

2020 ◽  
pp. 026921552096532
Author(s):  
Daryl Lawson ◽  
Kevin H Lee ◽  
Hyun Bin Kang ◽  
Nan Yang ◽  
Tracy Llewellyn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Knee Pain ◽  
Rating Scale ◽  
Short Form ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Physical Function Score ◽  
Double Blinded ◽  
Acute Knee

Objective: We would like to determine whether electrotherapy, specifically microcurrent therapy, increases function and decreases pain in people who have acute knee pain. Design: Randomized, double-blinded, placebo-controlled clinical trial. Setting: University laboratory and patient home. Subjects: A total of 52 subjects (35 females and 17 males) with acute knee pain. Intervention: Treatment group ( n = 26) wore the active microcurrent therapy device at home for 3 hours per day for 4 weeks and the control group ( n = 26) wore the placebo for 3 hours per day for 4 weeks. Main Measures: Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale were used to measure the pain level and the functionality of the participants. Secondary assessments included musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS). Results: A total of 52 subjects completed the study; 26 in the treatment group and 26 in the control group. Microcurrent therapy significantly reduced pain over 4 weeks. Especially week three was significant ( P < 0.01) after adjusting for the family-wise error rate. The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three. Conclusion: An active microcurrent therapy device decreased knee pain and increased function. Microcurrent therapy may be an alternative or used with a pharmacological approach for people with acute knee pain.

Interferential current and photobiomodulation in knee osteoarthritis: A randomized, placebo-controlled, double-blind clinical trial

2021 ◽  
pp. 026921552110120
Author(s):  
Renata Alqualo-Costa ◽  
Érika Patrícia Rampazo ◽  
Gustavo Ribeiro Thome ◽  
Mônica Rodrigues Perracini ◽  
Richard Eloin Liebano
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Pain Intensity ◽  
Rating Scale ◽  
Pain Modulation ◽  
Double Blind ◽  
Time Points ◽  
Double Blind Clinical Trial ◽  
Interferential Current

Objectives: To evaluate the effects of interferential current and photobiomodulation in patients with knee osteoarthritis. Design: A randomized, placebo-controlled, double-blind clinical trial. Setting: Physiotherapy Clinic of City University of São Paulo. Subjects: A total of 184 patients with knee osteoarthritis were recruited and, of these, 168 were included and randomized into four groups with 42 each: interferential current, photobiomodulation, interferential current plus photobiomodulation or placebo groups. One hundred and sixty-four patients completed the study. Intervention: Patients received 12 sessions (three times a week) of treatment: 30 minutes of interferential current (active or placebo) followed by photobiomodulation (active or placebo). Main measures: Primary outcome: pain intensity at rest and during movement (numeric rating scale) after 12 sessions. Secondary outcomes: functional capacity (Timed Up & Go and Sit and Lift tests and Lequesne and WOMAC questionnaires), pressure pain threshold, conditioned pain modulation, and muscle strength production (isokinetic evaluation). Patients were assessed at baseline, after 12 sessions, and three and six months after the end of the treatment. Results: Interferential current plus photobiomodulation reduced pain intensity at rest and during movement compared to placebo and interferential current at all time points ( P < 0.05). Photobiomodulation reduced pain intensity at rest compared to placebo at all time points ( P < 0.05) and compared to interferential current at six months follow-up ( P < 0.05). Photobiomodulation reduced pain intensity during movement compared to placebo at six months follow-up ( P < 0.05). Conclusion: Interferential current plus photobiomodulation or isolated photobiomodulation improve pain intensity in knee osteoarthritis.

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