Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

NCT02205502 | Unknown Phase 4

• 1 other identifier: Lidocaine-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Ketamine seems an obvious choice in the setting of an emergency department in laceration repair. Lidocaine is the local anesthetics widespread used. Ketamine leads to dissociative amnesia. Theoretically , lidocaine is not useful in laceration repair using ketamine. However, lidocaine is used with ketamine in many emergency department. The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure

Conditions

Conscious Sedation Failure During Procedure; Analgesia; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Children's Hospital of Eastern Ontario Pain Scale (CHEOPS

  The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.

  up to 1 hour

Secondary Outcomes (3)

• Sedation scale

  up to 1 hour

• Complication

  up to 1 hour

• Satisfaction of parents and clinicians

  up to 1 hour

Study Arms (2)

Lidocaine

EXPERIMENTAL

Proper amount of lidocaine will be injected lacerated wound. * dosage form: fluid * dosage: not exceeding 1mg/kg * frequency: once * duration: n/a

Drug: Lidocaine

Normal saline

PLACEBO COMPARATOR

Normal saline will be used as a placebo for lidocaine

Drug: Normal saline

Interventions

Lidocaine DRUG

Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.

Lidocaine

Normal saline DRUG

Normal saline

Eligibility Criteria

• Age: 12 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients who need suturing for laceration under procedural anesthesia using ketamine

You may not qualify if:

• contraindication to ketamine and lidocaine
• patients involved to other studies
• more or equal to American Society of Anesthesiologist (ASA) class III
• not alert

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jin Hee Lee, Professor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Jin Hee Lee,, Professor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Hee Lee, Professor

CONTACT

+82-31-787-7575; gienee@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: July 31, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

KR (1)