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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.
Demographic information (age, sex, ethnicity).
Clinical history and physical examination (Heart rate, Hypertension, Respiratory rate, burn percentage …. etc).
Intervention:
Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. (Green et al., 1998).
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 recorded. According to randomization that will be done by a computerized program, the drug will be administered to the patients in the preparation room by a researcher who will not participate in the evaluation of the patients before transfer to the operation room (OR).
Parents are not allowed to accompany their children to the OR according to the hospital policy.
Upon arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients will receive nebulized ketamine | Active Comparator | 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. |
|
| Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 | Active Comparator | 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. |
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| - Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before | Active Comparator | - 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group (1): Patients will receive nebulized ketamine (2 mg/kg) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries |
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 | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries |
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marihan A Lwiz, MBBCH,M.Sc. | Teaching assistant Ain Shams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
All data will be shared once study is completed
1/2028
Free
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| Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg) | Drug | 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 |
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| Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. | Drug | 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 |
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| 1 hour |
| 10 minutes |
| Recovery time | How long will the patient need to be fully conscious | 1 hour |
| ID | Term |
|---|---|
| D044382 | Population Groups |
| D007649 | Ketamine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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