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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06139380

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Intranasal Ketamine	Drug: Ketamine Drug: Sterile water	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2-group parallel double blind randomized controlled trial2-group parallel double blind randomized controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2024

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

Jun 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intranasal ketamine	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.
Placebo Comparator: Intranasal sterile water	Drug: Sterile water Intranasal sterile water was administered via syringe.

Arm

Intervention/Treatment

Active Comparator: Intranasal ketamine

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.

Placebo Comparator: Intranasal sterile water

Drug: Sterile water

Intranasal sterile water was administered via syringe.

Outcome Measures

Primary Outcome Measures

Intramuscular injection pain [immediately after Intramuscular injection]
This will be assessed at the time of injection using FLACC scale.

Secondary Outcome Measures

Hospital stay duration [1 hours on average]
This will be assessed using modified Ramsay's sedation scale.
Adverse effects [1 hours on average]
This will be assessed using the standard definition of the adverse effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IKHC	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadi Mirfazaelian, Assistant Professor of Emergency Medicine, Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT06139380

Other Study ID Numbers:

9911307010

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ketamine

Study Results

No Results Posted as of Nov 18, 2023