Intranasal Ketamine, Pain
Conditions
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.
Interventions
DRUGKetamine
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.
DRUGSterile water
Intranasal sterile water was administered via syringe.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
We will blind medication administrator, care provider, and assessor in addition to the patients.
Intervention model description
2-group parallel double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
12 Months to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intramuscular injection pain | immediately after Intramuscular injection | This will be assessed at the time of injection using FLACC scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Iran
Outcome results
None listed