A Phase 1 interventional study of Group (1): Patients will receive nebulized ketamine (2 mg/kg) and Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg) in Inhalation Anesthesia, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 3 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Ain Shams University · Phase 1, Interventional, and Other
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
Written informed consent will be obtained from parents of all participants prior to the study.
Intervention:
Upon entering the operation room, standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. An attempt of cannulation will be done by an expert.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Drug: Group (1): Patients will receive nebulized ketamine (2 mg/kg)
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.
Drug: Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg)
\- Group (3): 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.
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 willbe rec
Also known as: Not present
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
Also known as: Nebulized ketamine and precedex
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
Also known as: Not present
Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries
* The primary outcome will be depth of sedation evaluated by (UMSS) upon transfer to OR (after patient separation) * During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 3 mg/kg propofol as a rescue dose if vital data increased by \>20% of the baseline. Sedation will be assessed by University of Michigan Sedation Scale (UMSS) Value Patient state 0 Awake and alert Minimally sedated: tired/sleepy, appropriate response to verbal conversation, and/or sound 2 Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command 3 Deeply sedated: deep sleep, aroused only with significant physical stimulation 4 Unarousable
Time frame: 5 minutes
Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries
* analgesic effect using FLACC * After the completion of procedure, patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min. During the stay in PACU pain will also be assessed by using FLACC score: Behavior 0 1 Face No particular expression or smile Occasional grimace or frown, withdrawn, disinterested Legs Normal position or relaxed Uneasy, restless, tense Activity Lying quietly, normal position, moves easily Squirming, shifting, back and forth, tense Cry No cry (awake or asleep) Moans or whimpers; occasional complaint Consolability Content, relaxed Reassured by touching, hugging, or being talked to, distractible
Time frame: 1 hour
Parental seperation anxiety scale
\- Upon arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated according to the following: Behavior of the child during separation from parents Criteria score Excellent Patient unafraid, cooperative, or asleep 1 Good Slightly afraid/crying, quiet with reassurance 2 Fair Moderately afraid and crying not quit with reassurance 3 Poor Crying, need for restraint 4
Time frame: 10 minutes
Recovery time
How long will the patient need to be fully conscious
Time frame: 1 hour
Plan to share: Yes — All data will be shared once study is completed
Supporting information: Study protocol, Sap, Icf
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Ain Shams University