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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal ketamine | Active Comparator |
| |
| Intranasal sterile water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intramuscular injection pain | This will be assessed at the time of injection using FLACC scale. | immediately after Intramuscular injection |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay duration | This will be assessed using modified Ramsay's sedation scale. | 1 hours on average |
| Adverse effects | This will be assessed using the standard definition of the adverse effects. |
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Inclusion Criteria:
• Children who need to undergo procedural sedation and analgesia
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IKHC | Tehran | Iran |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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2-group parallel double blind randomized controlled trial
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We will blind medication administrator, care provider, and assessor in addition to the patients.
| Sterile water | Drug | Intranasal sterile water was administered via syringe. |
|
| 1 hours on average |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |