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OpenTrials
Completed

NCT Number: NCT06139380

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

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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Key information

Conditions

Pain Intranasal Ketamine Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IKHC

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sterile water

Drug

Intranasal sterile water was administered via syringe.

Primary outcomes

  1. Intramuscular injection pain

    Time frame: immediately after Intramuscular injection

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

Secondary outcomes

  1. Hospital stay duration

    Time frame: 1 hours on average

    This will be assessed using modified Ramsay's sedation scale.

  2. Adverse effects

    Time frame: 1 hours on average

    This will be assessed using the standard definition of the adverse effects.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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