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

NCT06139380 | Completed Phase 4

• 1 other identifier: 9911307010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Intranasal Ketamine

Outcome Measures

Primary Outcomes (1)

• Intramuscular injection pain

  This will be assessed at the time of injection using FLACC scale.

  immediately after Intramuscular injection

Secondary Outcomes (2)

• Hospital stay duration

  1 hours on average

• Adverse effects

  1 hours on average

Study Arms (2)

Intranasal ketamine

ACTIVE COMPARATOR

Drug: Ketamine

Intranasal sterile water

PLACEBO COMPARATOR

Drug: Sterile water

Interventions

Ketamine 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 ketamine

Sterile water DRUG

Intranasal sterile water was administered via syringe.

Intranasal sterile water

Eligibility Criteria

• Age: 12 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who need to undergo procedural sedation and analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

IKHC

Tehran, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will blind medication administrator, care provider, and assessor in addition to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Model Details: 2-group parallel double blind randomized controlled trial

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: December 2, 2023
• Primary Completion: April 28, 2024
• Study Completion: May 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)