Inhalation AnesthesiaPhase 1NCT07086690
Comparing Nebulized Ketamine,Nebulized Ketamine and Precedex and IM Ketamine for Analgesia in Pediatric Burn
A Phase 1 study testing 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) and Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. in people with Inhalation Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhalation Anesthesia
- What is being tested?
- 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) and Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2025to 16 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) physical status I \& II
- Pediatrics aged from 3 to 10 years.
- Both genders
- Pediatrics that has burn injuries and need sedation for cannulation and dressing.
- Burn >5% body surface area and <20% of surface area
Who cannot join
- ASA III and V patients with history of chronic illness
- Patients with known allergy/hypersensitivity to the study drug
- Congenital diseases or developmental delay or with neurological disease,
- known case of bronchial asthma or difficult airway were excluded from the study
- parents' refusal for participation in the study
- Emergency surgeries with hemodynamic instability
Show all 10Show fewer
- mental retardation,
- neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
- treatment with anticonvulsants and sedatives
- Major sepsis or extensive infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Nebulized Ketamine, Nebulized Combination of Ketamine and Dexmedetomidine and Intramuscular Ketamine for Procedural Sedation and Analgesia in Pediatric Burn Injuries
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
Read the detailed description
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 (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.
- 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.
- 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) 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.
- Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital
- Conditions
- Inhalation Anesthesia
- Being tested
- 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), Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group (1): Patients will receive nebulized ketamine (2 mg/kg)Drug
Also called 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 willbe rec
Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg)Drug
Also called 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
Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.Drug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | 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. Receives: 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 | 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. Receives: Drug: Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Secondary outcomes (1)
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start16 Apr 2025
- Primary completion16 Apr 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marihan A Lwiz, MBBCH,M.Sc., Principal investigator, Teaching assistant Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086690
- Sponsor's protocol ID
- FMASU MD89/2025
- Status last verified
- Apr 2025
- First submitted
- 21 May 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Nebulized Ketamine, Nebulized Combination of Ketamine and Dexmedetomidine and Intramuscular Ketamine for Procedural Sedation and Analgesia in Pediatric Burn Injuries
- ClinicalTrials.gov ID
- NCT07086690
- Acronym / sponsor ID
- FMASU MD89/2025
- Conditions
- Inhalation Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 16 Apr 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 (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.
- 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.
- 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) 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.
- Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients will receive nebulized ketamine | Active comparator | Drug: Group (1): Patients will receive nebulized ketamine (2 mg/kg)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 | Drug: Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 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. |
| - Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before | Active comparator | Drug: Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.- 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. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients of American Society of Anesthesiologists (ASA) physical status I \& II
- Pediatrics aged from 3 to 10 years.
- Both genders
- Pediatrics that has burn injuries and need sedation for cannulation and dressing.
- Burn >5% body surface area and <20% of surface area
Key exclusion criteria (10 listed)
- ASA III and V patients with history of chronic illness
- Patients with known allergy/hypersensitivity to the study drug
- Congenital diseases or developmental delay or with neurological disease,
- known case of bronchial asthma or difficult airway were excluded from the study
- parents' refusal for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group (1): Patients will receive nebulized ketamine (2 mg/kg)Also: Not presentDrugs 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 | Patients will receive nebulized ketamine |
| Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 mg/kg)Also: Nebulized ketamine and precedexDrugs 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 | Group (2): Patients will receive nebulized combination of dexmedetomidine and ketamine (1 μg/kg + 1 |
| Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure.Also: Not presentDrugs 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 | - Group (3): Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before |
Primary outcome
Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries
Time frame: 5 minutes
* 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
1 secondary outcome
Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marihan A Lwiz, MBBCH,M.Sc. principal investigator
Teaching assistant Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 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) and Patients will receive intramuscular ketamine (4 mg/kg, intramuscularly) 15 mins before starting the procedure. in people with Inhalation Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative evaluation of nebulized ketamine, nebulized combination of ketamine and dexmedetomidine and intramuscular ketamine for procedural sedation and analgesia in pediatric burn injuries (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.