Dental SurgeriesNCT04226885
Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Premedication in Pediatric Dental Surgeries
A study testing fentanyl, midazolam and dexmedetomidine in people with Dental Surgeries, run by Zagazig University at 1 site in Egypt.
Trial summary
The preoperative time can be traumatic for young children undergoing surgery. Pediatric anesthesiologists act strongly to decrease distress for children in the operating room (OR) and to provide a smooth induction of anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Surgeries
- What is being tested?
- fentanyl, midazolam and dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent acceptance.Children 2-6 years old of either sex.12-18 kg body weight. american society of anesthesiologist I-II.outpatients dental surgeries under general anesthesia.
Who cannot join
- Difficult airway .central nervous system dysfunction.Advanced Cardiovascular ,liver, renal diseases. Allergy to the drugs under study. Patients with any intranasal pathology or congenital anomaly.Patient refusal to take the inhaled premeditation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine,Zagazig University
Zagazig, Zagazig, Elsharkia,egypt, 44519
About this study
Official title: Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Sedative Premedication in Outpatient Pediatric Dental Surgeries : A Randomized Double Blind Study.
- The preoperative time can be traumatic for young children undergoing surgery. Pediatric anesthesiologists act strongly to decrease distress for children in the operating room (OR) and to provide a smooth induction of anesthesia.
- Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction and easy separation of children from their parents.
- This study was designed to evaluate and compare the effect and safety of nebulized either fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication prior to general anesthesia (GA) in outpatient pediatric dental surgeries.
Read the detailed description
The preoperative time can be traumatic for young children undergoing surgery. Pediatric anesthesiologists act strongly to decrease distress for children in the operating room (OR) and to provide a smooth induction of anesthesia(1). Parentral separation and needle injection increase preoperative anxiety. Preoperative stress response stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability(2,3) . Dental procedures are assiociated by high rate of fear and anxiety in children (4).
Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction and easy separation of children from their parents. The ideal premedication especially in children must be acceptable with rapid onset ,minimal side effects and with rapid postoperative recovery and return to alertness (5,6).
Fentanyl is a potent analgesic opioid with a rapid onset, and short duration of action (7). Midazolam is a short-acting benzodiazepine that has anxiolytic, amnestic, hypnotic, anticonvulsant and muscle relaxant actions (8,9). Dexmedetomidine is a selective α-2 adrenergic agonist that has both sedative and analgesic effects (10-12)
Preoperative sedation in children is usually administered via the rectal, oral sublingual, and intranasal routes with different degrees of patient acceptance.(13-18). Nebulized drug is an alternative method of sedation that is relatively easy to set up, without need for venipuncture, and is associated with high bioavailability of the drug (19,20).
This study was designed to evaluate and compare the effect and safety of nebulized either fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication prior to general anesthesia (GA) in outpatient pediatric dental surgeries. The primary end point is the time of sedation and level of sedation when the child is first seen in the operating room(OR) 30 minutes after using studied drugs, based on the Modified Observer's Assessment of Alertness/Sedation Scale(19). The secondary end points are parentral separation, tolerance to mask induction, reaction to intravenous cannulation, hemodynamic changes( systolic blood pressure, diastolic blood pressure and heart rate), sedation at emergence and wake-up behavior.
- Conditions
- Dental Surgeries
- Being tested
- fentanyl, midazolam, dexmedetomidine
- Keywords
- fentanyl ,midazolam, dexmeditomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Also called fentanyl,
nebulized fentanyl 2μg/kg body weigh
midazolamDrug
Also called dormicum
nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.
dexmedetomidineDrug
Also called precedex
nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | patients will be given nebulized fentanyl 2μg/kg body weight 30 min before surgery Receives: Drug: fentanyl |
| midazolam | Active comparator | The patients will be given nebulized midazolam 0.2 mg/kg body weight 30 min before surgery. Receives: Drug: midazolam |
| dexmedetomidine | Active comparator | The patients will be given nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery. Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
of onset of sedation
onset of sedation based on the Modified Observer's Assessment of Alertness/Sedation Scale 6Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus
Measured: Baseline (before surgery)
Secondary outcomes (2)
Heart rate
hemodynamic changes
Measured: Baseline (before surgery) and intraoperative
systolic and diastolic blood pressure
hemodynamic changes
Measured: Baseline (before surgery) and intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Mar 2019
- Primary completion20 Jan 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental SurgeriesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226885
- Sponsor's protocol ID
- 5742-3-12-2019
- Status last verified
- Apr 2021
- First submitted
- 5 Jan 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after completion of the study and publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Sedative Premedication in Outpatient Pediatric Dental Surgeries : A Randomized Double Blind Study.
- ClinicalTrials.gov ID
- NCT04226885
- Acronym / sponsor ID
- 5742-3-12-2019
- Conditions
- Dental Surgeries
- Keywords
- fentanyl ,midazolam, dexmeditomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 13 Jan 2020 (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 preoperative time can be traumatic for young children undergoing surgery. Pediatric anesthesiologists act strongly to decrease distress for children in the operating room (OR) and to provide a smooth induction of anesthesia.
- Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction and easy separation of children from their parents.
- This study was designed to evaluate and compare the effect and safety of nebulized either fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication prior to general anesthesia (GA) in outpatient pediatric dental surgeries.
Detailed description
The preoperative time can be traumatic for young children undergoing surgery. Pediatric anesthesiologists act strongly to decrease distress for children in the operating room (OR) and to provide a smooth induction of anesthesia(1). Parentral separation and needle injection increase preoperative anxiety. Preoperative stress response stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability(2,3) . Dental procedures are assiociated by high rate of fear and anxiety in children (4).
Many drugs have been used as premedication to decrease anxiety , facilitate smooth induction and easy separation of children from their parents. The ideal premedication especially in children must be acceptable with rapid onset ,minimal side effects and with rapid postoperative recovery and return to alertness (5,6).
Fentanyl is a potent analgesic opioid with a rapid onset, and short duration of action (7). Midazolam is a short-acting benzodiazepine that has anxiolytic, amnestic, hypnotic, anticonvulsant and muscle relaxant actions (8,9). Dexmedetomidine is a selective α-2 adrenergic agonist that has both sedative and analgesic effects (10-12)
Preoperative sedation in children is usually administered via the rectal, oral sublingual, and intranasal routes with different degrees of patient acceptance.(13-18). Nebulized drug is an alternative method of sedation that is relatively easy to set up, without need for venipuncture, and is associated with high bioavailability of the drug (19,20).
This study was designed to evaluate and compare the effect and safety of nebulized either fentanyl, midazolam or nebulized dexmedetomidine as a sedative premedication prior to general anesthesia (GA) in outpatient pediatric dental surgeries. The primary end point is the time of sedation and level of sedation when the child is first seen in the operating room(OR) 30 minutes after using studied drugs, based on the Modified Observer's Assessment of Alertness/Sedation Scale(19). The secondary end points are parentral separation, tolerance to mask induction, reaction to intravenous cannulation, hemodynamic changes( systolic blood pressure, diastolic blood pressure and heart rate), sedation at emergence and wake-up behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: fentanylpatients will be given nebulized fentanyl 2μg/kg body weight 30 min before surgery |
| midazolam | Active comparator | Drug: midazolamThe patients will be given nebulized midazolam 0.2 mg/kg body weight 30 min before surgery. |
| dexmedetomidine | Active comparator | Drug: dexmedetomidineThe patients will be given nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parent acceptance.Children 2-6 years old of either sex.12-18 kg body weight. american society of anesthesiologist I-II.outpatients dental surgeries under general anesthesia.
Key exclusion criteria (1 listed)
- Difficult airway .central nervous system dysfunction.Advanced Cardiovascular ,liver, renal diseases. Allergy to the drugs under study. Patients with any intranasal pathology or congenital anomaly.Patient refusal to take the inhaled premeditation.
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 |
|---|---|---|
| fentanylAlso: fentanyl,nebulized fentanyl 2μg/kg body weigh | Drug | fentanyl |
| midazolamAlso: dormicumnebulized midazolam 0.2 mg/kg body weight 30 min before surgery. | Drug | midazolam |
| dexmedetomidineAlso: precedexnebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery. | Drug | dexmedetomidine |
Primary outcome
of onset of sedation
Time frame: Baseline (before surgery)
onset of sedation based on the Modified Observer's Assessment of Alertness/Sedation Scale 6Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus
2 secondary outcomes
Heart rate
Time frame: Baseline (before surgery) and intraoperative
systolic and diastolic blood pressure
Time frame: Baseline (before surgery) and intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: Yes. planned after completion of the study and publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl, midazolam and dexmedetomidine in people with Dental Surgeries, run by Zagazig 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Apr 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
of onset of sedation (time frame: Baseline (before surgery)). 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 21 Apr 2021.