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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Intranasal Ketamine; Pain

Treatments: Drug: Ketamine; Drug: Sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT06139380

9911307010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 12 months to 7 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Intranasal ketamine

Active Comparator group

Treatment:

Drug: Ketamine

Intranasal sterile water

Placebo Comparator group

Treatment:

Drug: Sterile water