Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children
- Registration Number
- NCT06139380
- Lead Sponsor
- Tehran University of Medical Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
• Children who need to undergo procedural sedation and analgesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intranasal ketamine Ketamine - Intranasal sterile water Sterile water -
- Primary Outcome Measures
Name Time Method Intramuscular injection pain immediately after Intramuscular injection This will be assessed at the time of injection using FLACC scale.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
IKHC
🇮🇷Tehran, Iran, Islamic Republic of