Clinical trial

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

Name

9911307010

Description

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.

Trial arms

Trial start

2023-12-02

Estimated PCD

2024-04-28

Trial end

2024-05-31

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Intranasal ketamine

Sterile water

Intranasal sterile water was administered via syringe.

Arms:

Intranasal sterile water

Size

Primary endpoint

Intramuscular injection pain

immediately after Intramuscular injection

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2-group parallel double blind randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'We will blind medication administrator, care provider, and assessor in addition to the patients.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}

Updated at

2024-06-04

1 organization

1 product

1 drug

2 indications

Organization

Tehran University of Medical Sciences

Drug

Indication

Indication

Product