Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Conscious Sedation Failure During Procedure Analgesia Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine

Proper amount of lidocaine will be injected lacerated wound.

* dosage form: fluid
* dosage: not exceeding 1mg/kg
* frequency: once
* duration: n/a

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Normal saline

Normal saline will be used as a placebo for lidocaine

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Interventions

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Lidocaine

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

Intervention Type DRUG

Normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No