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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06139380
• Other study ID #: 9911307010
• Status: Completed
• Phase: Phase 4
• Start date: December 2, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 31, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Intranasal Ketamine
• Pain

Intervention

Drug:
• 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.
• Sterile water
Intranasal sterile water was administered via syringe.

Locations

Country	Name	City	State
Iran, Islamic Republic of	IKHC	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intramuscular injection pain	This will be assessed at the time of injection using FLACC scale.	immediately after Intramuscular injection
Secondary	Hospital stay duration	This will be assessed using modified Ramsay's sedation scale.	1 hours on average
Secondary	Adverse effects	This will be assessed using the standard definition of the adverse effects.	1 hours on average