Anesthesia, LocalNCT04991298
Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication
A study testing Oral premedication in people with Anesthesia, Local, run by University of Alexandria at 2 sites in Egypt.
Trial summary
evaluate the efficacy of the intravenous formulation of fentanyl citrate administered orally as a sedative premedication, we will compare it with oral midazolam, as a gold standard premedication, in paediatric congenital cardiac surgeries Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Oral premedication
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2021to 25 Jul 2022
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- paediatric congenital heart disease patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease
Who cannot join
- Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Alexandria university
Alexandria, 23541
Nagwa Kobea, Phd, +20 122 336 8233, kobea@yahoo.com
- Recruiting
Alexandria university
Alexandria, 24356
Nagwa Kobea, Phd, +20 122 336 8233, kobea@yahoo.com
About this study
Official title: Efficacy of the Intravenous Formulation of Fentanyl Citrate Administered Orally as Premedication in Paediatric Patients Undergoing Open Cardiac Surgery
evaluate the efficacy of the intravenous formulation of fentanyl citrate administered orally as a sedative premedication, we will compare it with oral midazolam, as a gold standard premedication, in paediatric congenital cardiac surgeries
Read the detailed description
In this double-blinded randomized controlled study, after approval by the local ethics committee, paediatric patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease will be enrolled. Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded. After assessing the patient for anaesthesia, informed consent of patients about study and anaesthesia will be obtained.Children will be kept off solid food for 6 hours and of clear fluids for 2 hours. The premedication will be administered orally mixed with equal volume of 5% dextrose and using a 5-ml syringe, 30 minutes before admission to operating room by a member of the nursing staff unaware of the group allocation, in the preoperative holding area, in the presence of one parent. A randomized block design will be used for allocation of patients into two groups (50 patients each); one group of patients will receive midazolam (Group M) and the other will receive fentanyl (Group F) as a sedative premedication.
- Group M: patients will be premedicated with the undiluted IV formulation of Midazolam (5 mg/mL), 0.5 mg/kg up to 15 mg per patient. The dose is chosen to be similar to the dose of midazolam used in other previous studies ().
- Group F: patients will be premedicated with the undiluted IV formulation of fentanyl citrate (50 µg/mL), 10 µg/kg up to 400 µg per patient. The dose is chosen to be similar to the dose of OTFC used in other previous studies
- Conditions
- Anesthesia, Local
- Being tested
- Oral premedication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral premedicationDrug
Also called Midazolam , fentanyl
Oral anesthesia premedication for congenital Cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | patients will be premedicated with the undiluted IV formulation of Midazolam Receives: Drug: Oral premedication |
| Group F | Active comparator | patients will be premedicated with the undiluted IV formulation of fentanyl citrate Receives: Drug: Oral premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's acceptance of the medication (score from 1 to 3)
Response of the child to acceptance of premedication will be assessed on a three-point scale:
- = Spits/vomits the premedication.
- = Accepts it/but dislikes the taste.
- = Accepts it/likes the taste.
Measured: 1 year
Reaction to separation from parents (score from 1 to 4)
The response of the children when taken away from the parents will be recorded as the end point of premedication. It will be assessed on a four point scale:
- = Inconsolable cry.
- = Complaining.
- = Quiet but awake.
- = Sleepy.
Measured: 1 year
Sedation score ( score from 1 to 6)
The degree of sedation, when the child will be first seen in the operating room (OR), will be scaled from 1 to 6 according to the Ramsay Sedation Scale.
- =Anxious and agitated or restless, or both.
- =Cooperative, oriented, and calm.
- =Responsive to commands only.
- =Exhibiting brisk response to light glabellar tap or loud auditory stimulus.
- =Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus.
- =Unresponsive.
Measured: 1 year
Ease of Induction of general anaesthesia (score from 1 to 4)
A 4-point scoring system will used to evaluate the child's behaviour at anaesthesia induction and mask acceptance
1= Calm and cooperating 2 =Anxious but without resistance 3 =Anxious with slight resistance 4 =Crying and/or struggling against mask
Measured: 1 year
Secondary outcomes (2)
Hemodynamic effects
Heart rate (beats/min)
Measured: 1 year
Adverse effects
nausea, vomiting, illusion, pruritis, paradoxical hyperactive reactions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jun 2021
- Primary completion25 Jun 2022 (estimated)
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mabrouk Ibrahim, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991298
- Sponsor's protocol ID
- 124
- Status last verified
- Aug 2021
- First submitted
- 27 May 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Intravenous Formulation of Fentanyl Citrate Administered Orally as Premedication in Paediatric Patients Undergoing Open Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04991298
- Acronym / sponsor ID
- 124
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 5 Aug 2021 (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.
evaluate the efficacy of the intravenous formulation of fentanyl citrate administered orally as a sedative premedication, we will compare it with oral midazolam, as a gold standard premedication, in paediatric congenital cardiac surgeries
Detailed description
In this double-blinded randomized controlled study, after approval by the local ethics committee, paediatric patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease will be enrolled. Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded. After assessing the patient for anaesthesia, informed consent of patients about study and anaesthesia will be obtained.Children will be kept off solid food for 6 hours and of clear fluids for 2 hours. The premedication will be administered orally mixed with equal volume of 5% dextrose and using a 5-ml syringe, 30 minutes before admission to operating room by a member of the nursing staff unaware of the group allocation, in the preoperative holding area, in the presence of one parent. A randomized block design will be used for allocation of patients into two groups (50 patients each); one group of patients will receive midazolam (Group M) and the other will receive fentanyl (Group F) as a sedative premedication.
- Group M: patients will be premedicated with the undiluted IV formulation of Midazolam (5 mg/mL), 0.5 mg/kg up to 15 mg per patient. The dose is chosen to be similar to the dose of midazolam used in other previous studies ().
- Group F: patients will be premedicated with the undiluted IV formulation of fentanyl citrate (50 µg/mL), 10 µg/kg up to 400 µg per patient. The dose is chosen to be similar to the dose of OTFC used in other previous studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: Oral premedicationpatients will be premedicated with the undiluted IV formulation of Midazolam |
| Group F | Active comparator | Drug: Oral premedicationpatients will be premedicated with the undiluted IV formulation of fentanyl citrate |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- paediatric congenital heart disease patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease
Key exclusion criteria (1 listed)
- Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded.
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 |
|---|---|---|
| Oral premedicationAlso: Midazolam , fentanylOral anesthesia premedication for congenital Cardiac surgery | Drug | Group F, Group M |
Primary outcome
Patient's acceptance of the medication (score from 1 to 3)
Time frame: 1 year
Response of the child to acceptance of premedication will be assessed on a three-point scale: 1. = Spits/vomits the premedication. 2. = Accepts it/but dislikes the taste. 3. = Accepts it/likes the taste.
Reaction to separation from parents (score from 1 to 4)
Time frame: 1 year
The response of the children when taken away from the parents will be recorded as the end point of premedication. It will be assessed on a four point scale: 1. = Inconsolable cry. 2. = Complaining. 3. = Quiet but awake. 4. = Sleepy.
Sedation score ( score from 1 to 6)
Time frame: 1 year
The degree of sedation, when the child will be first seen in the operating room (OR), will be scaled from 1 to 6 according to the Ramsay Sedation Scale. 1. =Anxious and agitated or restless, or both. 2. =Cooperative, oriented, and calm. 3. =Responsive to commands only. 4. =Exhibiting brisk response to light glabellar tap or loud auditory stimulus. 5. =Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus. 6. =Unresponsive.
Ease of Induction of general anaesthesia (score from 1 to 4)
Time frame: 1 year
A 4-point scoring system will used to evaluate the child's behaviour at anaesthesia induction and mask acceptance 1= Calm and cooperating 2 =Anxious but without resistance 3 =Anxious with slight resistance 4 =Crying and/or struggling against mask
2 secondary outcomes
Hemodynamic effects
Time frame: 1 year
Adverse effects
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral premedication in people with Anesthesia, Local, run by University of Alexandria at 2 sites 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: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Mabrouk, Phd (00201224336786, ibrahim_wama@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's acceptance of the medication (score from 1 to 3) (time frame: 1 year). The study lists 4 primary outcomes in all. 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 5 Aug 2021.