Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2024-05-31

Brief Summary

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Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.

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Detailed Description

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Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.

Conditions

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Pain Intranasal Ketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-group parallel double blind randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

We will blind medication administrator, care provider, and assessor in addition to the patients.

Study Groups

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Intranasal ketamine

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

This is medication which is commonly used for sedation in the emergency department. At the analgesic dose, this medication can be used to reduce the pain via other routes such as intranasal.

Intranasal sterile water

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type DRUG

Intranasal sterile water was administered via syringe.

Interventions

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Ketamine

This is medication which is commonly used for sedation in the emergency department. At the analgesic dose, this medication can be used to reduce the pain via other routes such as intranasal.

Intervention Type DRUG

Sterile water

Intranasal sterile water was administered via syringe.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Children who need to undergo procedural sedation and analgesia

Exclusion Criteria

* Weight over 33 Kg
* No Consent from parents/patient
* Needs immediate procedure due to patient's condition
* Growth/mental retardation
* Sensory deficit at the site of intramuscular injection

Minimum Eligible Age

12 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No