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Laceration clinical trials

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NCT ID: NCT03199456 Completed - Laceration Clinical Trials

A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults

Start date: June 16, 2017
Phase: N/A
Study type: Interventional

The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.

NCT ID: NCT03080467 Completed - Child Clinical Trials

Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive

Start date: June 13, 2017
Phase:
Study type: Observational

This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.

NCT ID: NCT03071601 Completed - Pain, Acute Clinical Trials

Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department

Start date: December 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

NCT ID: NCT03053947 Completed - Laceration Clinical Trials

Pain Free Laceration Repairs Using Intra-nasal Ketamine

Start date: February 16, 2017
Phase: Phase 2
Study type: Interventional

Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ED. There is a growing interest in the intranasal (IN) route of administration in the pediatric population. It bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.

NCT ID: NCT02882256 Completed - Clinical trials for Urinary Tract Infection

Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions in the Emergency Department

Start date: June 2016
Phase: N/A
Study type: Interventional

Patients seen in the ED with either a laceration, minor head injury, or urinary tract infection will be randomized to one of two groups. Both groups will receive the standard written discharge instructions; in addition, one group will watch video discharge instructions. Each patient will be asked to complete a short survey with questions related to the discharge instructions received in the ED, and will be called 5-7 days after the ED visit to ask questions about discharge instructions and the ED visit.

NCT ID: NCT02168439 Active, not recruiting - Anxiety Clinical Trials

Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

Start date: June 2014
Phase: Phase 4
Study type: Interventional

The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.

NCT ID: NCT01911351 Active, not recruiting - Abscess Clinical Trials

Nitrous Oxide Use in Minor Procedures

Start date: July 2013
Phase: N/A
Study type: Interventional

Title: High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety during pediatric minor procedures. Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in addition to standard management increases the comfort level in pediatric patients undergoing minor procedures compared to standard management alone.

NCT ID: NCT01268670 Suspended - Pain Clinical Trials

The Addition of Oral Analgesics to LET During Laceration Repair

Start date: July 2012
Phase: N/A
Study type: Interventional

Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain. Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair? Design This is a double-blinded, randomized-controlled study. Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.

NCT ID: NCT00834730 Completed - Laceration Clinical Trials

Comparison of N2O Inhalation and Ketamine in Pediatric PSA

PSA
Start date: January 2009
Phase: Phase 4
Study type: Interventional

- Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients - However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies - We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients

NCT ID: NCT00451724 Completed - Laceration Clinical Trials

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Start date: May 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.