Treatment for Traumatic Tap

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CHU Sainte-Justine, Montréal, Canada
Traumatic Tap
Eligibility
< 65
All Sexes
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Study Summary

This study is evaluating whether a new technique for performing lumbar punctures can reduce the number of failed and traumatic lumbar punctures in children.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 7 secondary outcomes in patients with Traumatic Tap. Measurement will happen over the course of immediately after procedure.

1 hour after procedure
First-time lumbar puncture success rate
Lumbar puncture success rate despite the number of attempts
Proportion of final traumatic lumbar puncture
during procedure
Mean difference in Evendol pain scores and NRS-11 scores
immediately after procedure
Length of procedure
Number of changes in provider performing the lumbar puncture
Number of lumbar puncture attempts in total
Satisfaction with procedure

Trial Safety

Trial Design

2 Treatment Groups

Stylet-out
1 of 2
Stylet-in
1 of 2
Active Control

This trial requires 395 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Stylet-out
Procedure
The practitioner remove the stylet once he/she has passed the skin and moves the needle forward with the stylet.
Stylet-in
Procedure
Lumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediately after procedure for reporting.

Who is running the study

Principal Investigator
A. B. F.
Ariane Boutinc FRCPC, MD
St. Justine's Hospital

Closest Location

CHU Sainte-Justine - Montréal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All patients younger than 18 years of age (no minimal age)
will be offered the opportunity for research participation show original

Patient Q&A Section

How does treatment work?

"The most important determinants for successful management of [bloodstream infections with intraocular lenses are avoiding inappropriate antibiotic use and maintaining high standards of antimicrobial prescribing and prophylaxis]." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for traumatic tap?

"Results from a recent paper suggest that clinicians need to educate patients about the risk-benefit ratios of research. Patients were also found to be willing to participate in clinical trials to a greater extent than previous research has suggested." - Anonymous Online Contributor

Unverified Answer

How many people get traumatic tap a year in the United States?

"There are few documented cases of traumatic tap in the US. There was a significant correlation between the volume of procedures performed and the rate of traumatic tap, but the majority of traumatic tap events were less severe than traumatic tap in some other country." - Anonymous Online Contributor

Unverified Answer

What are common treatments for traumatic tap?

"Most traumatic tap patients with clinically significant injuries have nonoperative management. As a low risk procedure with low risks of complications, it should be used as a first line treatment for nonoperatively treated traumatic tap. If there are associated injuries requiring further intervention (ex. bony fractures, joint dislocations), further definitive treatment might be necessary." - Anonymous Online Contributor

Unverified Answer

What is traumatic tap?

"In general, traumatic taps heal relatively fast; however, the rate of wound closure may be delayed when surgical drainage is delayed. Patients with traumatic taps have greater need for antibiotics compared to those undergoing surgical drainage. A higher GCS and a low number of emergency department visits are associated with less infection risk." - Anonymous Online Contributor

Unverified Answer

What are the signs of traumatic tap?

"When evaluating an abdominal tap, many signs and symptoms, and even some of the signs pictured on the package insert, can be missed. While no one sign or symptom is diagnostic for traumatic tap, signs and symptoms of traumatic tap are still diagnostic for traumatic tap." - Anonymous Online Contributor

Unverified Answer

What causes traumatic tap?

"Traumatic tap is a severe complication of blunt trauma to the head. Patients need to be carefully evaluated and monitored for early diagnosis and intervention." - Anonymous Online Contributor

Unverified Answer

Can traumatic tap be cured?

"There is no known treatment for traumatic tap. However, there are many nonsurgical treatments aimed at reducing the pain. These include medical, psychological, and surgical intervention." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"The authors found a statistically and clinically significant decrease in the depth of an incision at six months after the trial initiation in both the placebo group and the treatment group (p = 0.008), and no change in the two-dimensional and three-dimensional measurements for the treatment group. We found no statistically or clinically significant change in the two-dimensional and three-dimensional measurements for the placebo group." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets traumatic tap?

"Most injuries are not associated with age. One-third of children had a traumatic tap as defined. Traumatic taps are a common injuries requiring evaluation for underlying pathology and will increase in prevalence with improved screening of child abuse." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Patient experience with treatment is in disagreement with that reported by the health care workers. Patient knowledge is important to support the quality of care for patients after shoulder injury. An example of treatment that may be better supported by the health care workers would be strengthening the arm and wrist using physiotherapy and bracing. Patient involvement improves long-term outcome following shoulder injury and supports the goals of the shoulder treatment programme." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"Common side effects seen frequently with RSI are tinnitus, vertigo, nausea, and vomiting. Severe side effects include coma, cerebral vascular accident, and seizures. Those with cohesinopathies may tolerate RSI better than others. People with cohesinopathies and cochlear deficits are less likely to tolerate RSI. Results from a recent paper have important ramifications to the decision of whether to use endoscopic retrograde cholangiopancreatography (ERCP) during acute pancreatitis. ERCP is often used in the management of common biliary diseases such as choledocholithiasis and complicated biliary strictures." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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