Ain Shams University
Cairo, Egypt
NCT Number: NCT07086690
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
This study is active but is not currently recruiting participants.
Notify Me3 year–10 year
All sexes
Interventional
Phase 1
Cairo, Egypt
Written informed consent will be obtained from parents of all participants prior to the study.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: 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.
Other names: Not present
Time frame: 5 minutes
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: 1 hour
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: 10 minutes
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: 1 hour
How long will the patient need to be fully conscious
Ain Shams University
Other
Comparative Evaluation of Nebulized Ketamine, Nebulized Combination of Ketamine and Dexmedetomidine and Intramuscular Ketamine for Procedural Sedation and Analgesia in Pediatric Burn Injuries
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