scholarly journals LO50: Pain free laceration repairs using intra-nasal ketamine: DosINK 2 clinical trial

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S25-S25
Author(s):  
S. Rached-Dastous ◽  
E. D. Trottier ◽  
Y. Finkelstein ◽  
B. Bailey ◽  
C. Marquis ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Procedural Sedation ◽  
Convenience Sample ◽  
Serious Adverse Event ◽  
Dental Procedures ◽  
Baseline Status ◽  
The Face ◽  
Repeated Doses ◽  
Prior Administration ◽  
Sedative Agents

Introduction: Lacerations are common in children presenting to the emergency department (ED). They are often uncooperative when sutures are needed and may require procedural sedation. Few studies have evaluated intranasal (IN) ketamine for procedural sedation in children, with doses from 3 to 9 mg/kg used mostly for dental procedures. In a previous dose escalation trial, DosINK-1, 6 mg/kg was found to be the optimal IN ketamine dose for procedural sedation for sutures in children. In this trial, we aim to further evaluate the efficacy of this dose. Methods: We conducted a multicentre single-arm clinical trial. A convenience sample of 30 uncooperative children between 1 and 12 years (10 to 30 kg) with no cardiac or kidney disease, active respiratory infection, prior administration of opioid or sedative agents received 6 mg/kg of IN ketamine using an atomizer for their laceration repair with sutures in the ED. The primary outcome was defined as the proportion (95% CI) of patients who achieved an adequate procedural sedation evaluated with the PERC/PECARN consensus criteria. Results: Thirty patients were recruited from April 2018 to November 2019 in 2 pediatric ED. The median age was 3.2 (interquartile range(IQR), 1.9 to 4.7) years-old with laceration of more than 2 cm in 20 (67%) patients and in the face in 21 (70%) cases. Sedation was effective in 18 out of 30 children 60% (95%CI, 45 to 80), was suboptimal in 6 patients (20%) with a procedure completed with minimal difficulties, and unsuccessful in the remaining 6 (20%), all without serious adverse event. Similarly, 21/30 (70%) physicians were willing to reuse IN ketamine at the same doses and 25 parents (83%) would agree to the same sedation in the future. Median time to return to baseline status was 58 min (IQR, 33 to 73). One patient desaturated during the procedure and required transitory oxygen and repositioning. After the procedure, 1 (3%) patient had headache, 1 (3%) patient had nausea, and 2 (7%) patients vomited. Conclusion: A single dose of 6 mg/kg of IN Ketamine for laceration repair with sutures in uncooperative children is safe and facilitated the procedure in 60% (95%CI, 45 to 80) of patients, was suboptimal in 20% and unsuccessful in 20% of patients. As seen with IV ketamine, an available additional dose of IN ketamine for some children if needed could potentially increase proportion of successful sedation. However, the safety and efficacy of repeated doses needs to be addressed.

scholarly journals 86 Intra-nasal ketamine for laceration repair in the Emergency Department: The DosINK studies

2020 ◽  
Vol 25 (Supplement_2) ◽  
pp. e35-e36
Author(s):  
Soha Rached-d’Astous ◽  
Yaron Finkelstein ◽  
Benoit Bailey ◽  
Chistopher Marquis ◽  
Denis Lebel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Trial Design ◽  
Primary Outcome ◽  
Clinical Trial Design ◽  
Physician Satisfaction ◽  
Dose Finding ◽  
Procedural Sedation ◽  
Healthy Children ◽  
Convenience Sample

Abstract Introduction/Background Lacerations are common in children presenting to the emergency department (ED). Children can be uncooperative and in pain when repair with sutures is performed and may require procedural sedation. There is a growing interest in the intranasal (IN) route of administration for procedural sedation and pain control. In contrast to intravenous (IV) line placement, IN administration is relatively painless for the patient, is simple and rapid to administer by the healthcare provider and requires minimal training. Few studies have evaluated intranasal (IN) ketamine for procedural sedation in children, mostly for brief dental procedures, with doses between 3 to 9 mg/kg. Objectives We sought to determine the optimal IN ketamine dose for effective and safe procedural sedation for laceration repair with sutures in children aged 1 to 12 years presenting to the ED using a two-step (dosINK- 1 trial and dosINK-2 trial) dose-finding clinical trial design. Design/Methods We enrolled otherwise healthy children 1 to 12 years requiring PS for their laceration repair by sutures in the ED. DosINK-1 consisted in a single center 3 + 3 dose escalation trial design with an initial dose of 3 up to 9 mg/kg of IN ketamine. For each dose, 3 patients were enrolled. Escalation to the next dose was performed if sedation was unsuccessful without serious adverse event (SAE). This process was repeated until 6 consecutive patients reached adequate PS with a maximum of 1 SAE. The primary outcome was the optimal dose for adequate PS as per the PERC/PECARN consensus criteria. We subsequently conducted DosINK-2, a multicenter single-arm clinical trial. We enrolled a convenience sample of 30 children who all received the identified dose of IN ketamine from DosINK-1. The primary outcome was the proportion (95% CI) of patients who achieved adequate PS. Secondary outcomes included adverse events and parent, patient and physician satisfaction. Results In DosINK-1, 12 patients were recruited from April 2017 to March 2018 in one pediatric ED. Median age was 2.6 (interquartile range [IQR] 1.9, 3.7) years, 10 (85%) had facial laceration, and in 8 (67%) the laceration was >2 cm long. Sedation was adequate in 1/3 patients at doses of 3 and 4 mg/kg and in 3/3 patients at doses of 5 and 6 mg/kg, all without SAE. The identified dose of IN ketamine was 6 mg/kg. Nausea and vomiting in 4/12 (33%) patients were the only reported side effects. In DosINK-2, we recruited 30 patients from April 2018 to November 2019 in two pediatric EDs. The median age was 3.2 (IQR 1.9, 4.7) years; 21 (70%) had facial laceration, and in 20 (67%) the laceration was longer than 2 cm. Sedation was adequate in 18/30 (60% [95% CI 45, 80]) children, was suboptimal (procedure completed with minimal difficulties) in 6 (20%), was poor (struggle that interfered with procedure, competed with difficulty) in 3 (10%) and required additional sedative agents in 3 (10%) patients. Twenty-one (70%) physicians were willing to reuse IN ketamine at the same doses and 25 (83%) parents would agree to the same sedation in the future. Median time to return to baseline status was 58 min (IQR 33, 73). Two patients, including one who received supplemental IV ketamine, desaturated during the procedure and required oxygen by-mask and repositioning. After the procedure, 1(3%) patient had nausea, and 2(7%) vomited. Conclusion A single dose of 6 mg/kg of IN ketamine for PS during laceration repair by sutures in children in the ED was adequate in 60%(95% CI 45, 80). In an additional 20% PS was suboptimal, but procedures were completed with minimal difficulties only. IN ketamine, which saves painful IV insertion, was acceptable by most physicians and parents. An additional IN ketamine dose may further increase the proportion of adequate sedation, but its safety and efficacy should be examined.

scholarly journals P119: Pain free laceration repairs using intra-nasal ketamine: DosINK 1- A dose escalation clinical trial

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S99-S99
Author(s):  
S. Rached-dastous ◽  
B. Bailey ◽  
C. Marquis ◽  
M. Desjardins ◽  
D. Lebel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Dose Escalation ◽  
Optimal Dose ◽  
Dose Finding ◽  
Procedural Sedation ◽  
Secondary Outcome ◽  
Finding Study ◽  
Baseline Status ◽  
Set Up

Introduction: Laceration is common in children presenting to the emergency department (ED). They are often uncooperative related to pain and distressed during repair. Currently, there are wide variations regarding sedation and analgesia practices when sutures are required. There is a growing interest in the intranasal (IN) route for procedural sedation and pain control because of its effectiveness potential and ease of administration. Few studies have evaluated IN ketamine for procedural sedation in children with reported doses ranging from 3 to 9 mg/kg. The objective is to evaluate the optimal IN ketamine dose for effective and safe procedural sedation for laceration repair in children aged 1 to 12 years. Methods: A dose escalation clinical trial with an initial dose of 3 mg/kg of IN ketamine up to a maximum dose of 9 mg/kg in children 1 to 12 years old, using a 3+3 trial design. For each tested dose, 3 patients are enrolled. Escalation to the next dose is permitted if sedation is unsuccessful in at least one patient without serious adverse event (SAE). Regression to prior dose is warranted in the occurrence of two or more SEAs. This process is repeated until effective sedation for 6 patients at two consecutive doses is achieved with a maximum of 1 SAE or if regression occurs. The primary outcome is the optimal dose for successful procedural sedation as per the PERC/PECARN consensus criteria. Secondary outcome, namely, pain and anxiety levels, parent, patient and provider satisfaction, recovery time, length of stay in the ED, side effects and adverse event are recorded. Results: Nine patients have been recruited from March to December 2017 with median age of 2.9 years-old and with laceration length of 2 to 5 cm and with facial involvement in 55% of cases, respectively. Sedation was successful in 1/3, 1/3 and 3/3 of patients at doses of 3, 4, 5 mg/kg respectively, without any SAE. Median time from ketamine administration to return to baseline status and discharge were 35 and 98 min, respectively. We expect to complete patient recruitment in March 2018. Conclusion: The results from our trial is a groundwork for future dose-finding study. Pending study completion, a multicentric dose validation trial, is set up to further validate the optimal dose from dosINK1 trial. IN ketamine has the potential to improve the field of procedural sedation for children by introducing an effective IN agent with respiratory stability but without the need for an IV line insertion not otherwise needed.

scholarly journals Does sevoflurane add to outpatient procedural sedation in children? A randomised clinical trial

2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Hugo Sérgio de Oliveira Gomes ◽  
Heloisa de Sousa Gomes ◽  
Joji Sado-Filho ◽  
Luciane Rezende Costa ◽  
Paulo Sucasas Costa
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Procedural Sedation

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.

scholarly journals Emergency Drug Kits: Pharmacological and Technical Considerations

2014 ◽  
Vol 61 (4) ◽  
pp. 171-179 ◽  
Author(s):  
Daniel E. Becker
Keyword(s):  
Adverse Events ◽  
Continuing Education ◽  
General Anesthesia ◽  
Intraoperative Monitoring ◽  
Preoperative Assessment ◽  
Procedural Sedation ◽  
Dental Procedures ◽  
Dental Practices ◽  
Emergency Drugs ◽  
Technical Considerations

Abstract The risk for complications while providing dental procedures is greatest when caring for patients having significant medical compromise. It is comforting that significant adverse events can generally be prevented by careful preoperative assessment, along with attentive intraoperative monitoring and support. Nevertheless, the office team must be prepared to manage untoward events should they arise. This continuing education article will address basic emergency drugs that should be available in all dental practices and additional agents that become essential for those practices providing various levels of procedural sedation or general anesthesia.

scholarly journals Attitudes Of Transplant Nurses Toward Clinical Trials

2021 ◽  
Author(s):  
Olesya Kolisnyk
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Financial Support ◽  
Survey Method ◽  
Attitudes And Beliefs ◽  
Urban Hospital ◽  
Convenience Sample ◽  
Southern Ontario ◽  
Transplant Patients ◽  
Positive Attitudes

Nurses may have an important role in supporting patients' decision making about their participation in clinical trials. Nurses' views about clinical trials and patients' understanding of the clinical trial process may shape the role nurses play in these trials. Little is known about transplant nurses' attitudes and beliefs toward clinical trials. This quantitative study employed a survey method involving a convenience sample of transplant nurses (n=39) in an urban hospital in Southern Ontario to describe attitudes and beliefs of transplant nurses toward clinical trials. The results indicated that transplant nurses had positive attitudes and beliefs toward clinical trials. Specifically, outpatient coordinators and older nurses were more positive in their attitudes. Nurses perceived transplant patients were knowledgeable about clinical trials. The majority of nurses (85%) engaged in the conduct of clinical trials. Transplant nurses also suggested educational, administrative and financial support as beneficial to further enhance their participation in these trials.

scholarly journals Prolotherapy injections and physiotherapy used singly and in combination for lateral epicondylalgia: A single-blinded randomised clinical trial.

2019 ◽  
Author(s):  
Michael Yelland ◽  
David Rabago ◽  
Michael Ryan ◽  
Shu-Kay Ng ◽  
Dinusha Vithanachchi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tennis Elbow ◽  
Exercise Program ◽  
Clinical Trial Design ◽  
Clinical Effectiveness ◽  
Randomised Clinical Trial ◽  
Intention To Treat ◽  
Lateral Epicondylalgia ◽  
Baseline Status ◽  
Global Impression Of Change

Abstract Background Lateral epicondylalgia (tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of lateral epicondylalgia are hypertonic glucose plus lignocaine injections (prolotherapy) and a physiotherapist guided manual therapy/exercise program (physiotherapy). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with physiotherapy. Methods Using a single-blinded randomised clinical trial design, 120 participants with lateral epicondylalgia of at least six weeks’ duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), physiotherapy (weekly for 4 sessions) or combined (prolotherapy+physiotherapy). The Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.’ Analysis was by intention-to-treat. Results 88% completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The physiotherapy group exhibited greater reductions in PRTEE at 12 weeks than the prolotherapy group (p = 0.014).Conclusion There were no significant differences amongst the Physiotherapy, Prolotherapy and Combined groups in PRTEE and global impression of change measures over the course of the 12-month trial.

Catastrophically Ill Children, Access to Unregistered Medical Interventions, and Trial Recruitment Needs

2018 ◽  
pp. 44-58
Author(s):  
Thomas D. Hartvigsson ◽  
Udo Schuklenk
Keyword(s):  
Clinical Trial ◽  
Ebola Virus ◽  
Medical Center ◽  
High Viral Load ◽  
Placebo Control ◽  
Trial Recruitment ◽  
Best Interest ◽  
Governmental Organization ◽  
Medical Interventions ◽  
The Face

This chapter discusses the case of a young girl infected by the Ebola virus during the epidemic outbreak in West Africa. She arrives alone to a medical center run by a non-governmental organization and is relatively well, but she has a high viral load and will with all certainty die within a week. This chapter argues that, in the face of imminent and certain death, it is permissible for the doctors at the medical center to use unregistered medical interventions, if they deem it to be in the best interest of the child. It further argues that they are permitted to do so without enrolling the child in a clinical trial, if the unregistered intervention is not scarce and the trial has placebo control groups.

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