Comparing Nebulized Ketamine,Nebulized Ketamine and Precedex and IM Ketamine for Analgesia in Pediatric Burn
NCT07086690 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-07-25
Summary
The present study compares efficacy of nebulised ketamine and combination of nebulised dexmedetomidine and ketamine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries
Conditions
- Inhalation Anesthesia
Interventions
- DRUG
-
Group (1): Patients will receive nebulized ketamine (2 mg/kg)
Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia. \- All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs willbe rec
- DRUG
-
Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg)
Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia. \- All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be re
- DRUG
-
Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.
Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of oxygen at 6 L/min for 10 to 15 minutes. Treatment will be stopped when the nebulizer begin to sputter. All solutions will be prepared in identical syringes with matching random codes by an independent investigator not involved in the observation or the administration of the anesthesia. \- All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be re
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Principal Investigators
-
Marihan A Lwiz, MBBCH,M.Sc. · Teaching assistant Ain Shams university
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-16
- Primary Completion
- 2027-04-16
- Completion
- 2027-04-16
Countries
- Egypt
Study Locations
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