AnalgesicNCT06994273
Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries
A study testing Fentanyl and Dexmedetomidine in people with Analgesic and Sedative, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- What is being tested?
- Fentanyl and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Oct 2024
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 4 to 11 years.
- Both sexes.
- Children who required a minimum of 24 hrs of mechanical ventilation following open abdominal surgeries
Who cannot join
- Patients with significant congenital anomalies.
- Chromosomal abnormalities.
- Neurologic conditions prohibiting sedation evaluation.
- Neuromuscular diseases.
- Those receiving neuromuscular blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries. Randomized Controlled Trial
This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population.
Read the detailed description
Appropriate sedation and analgesia are essential components in the post-operative care of critically ill children in the pediatric intensive care unit (PICU), especially those who need mechanical ventilation.
Fentanyl is an opioid analgesic that is 50-100 times more potent than morphine. It is used frequently because of its ability to provide rapid analgesia. A single dose of fentanyl significantly reduced pain behaviors and changes in heart rate. It also increased the growth hormone level.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with significant sedative and analgesic effects. Some studies have investigated its role in adult and pediatric intensive care, as a primary sedative or a second line following failure of benzodiazepines or opioid sedation, as a bridge for extubation, for substance withdrawal, and to decrease intensive care unit (ICU) delirium.
- Conditions
- Analgesic, Sedative, Fentanyl, Dexmedetomidine, Infusion, Postoperative
- Being tested
- Fentanyl, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Patients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes.
DexmedetomidineDrug
Patients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl group | Experimental | Patients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes Receives: Drug: Fentanyl |
| Dexmedetomidine group | Experimental | Patients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning eligibility
The time from ventilator weaning eligibility was monitored until discharge.
Measured: 48 hours postoperatively
Secondary outcomes (3)
Time from eligibility to extubation
Time from eligibility to extubation was monitored until discharge.
Measured: 60 min postoperatively
Mean arterial pressure
Mean arterial pressure was continuously monitored and recorded at baseline and 2, 5, 10, 15, 30 minutes, 2, 6, 12, 24, and 48 hrs post-infusion initiation.
Measured: 48 hours post-infusion initiation
Heart rate
Heart rate was continuously monitored and recorded at baseline and 2, 5, 10, 15, 30 minutes, 2, 6, 12, 24, and 48 hrs post-infusion initiation.
Measured: 48 hours post-infusion initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Apr 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesicStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohamed Abotaleb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994273
- Sponsor's protocol ID
- 36264PR315/8/23
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Abotaleb AM, Elsheikh MR, Elshimy KM, AbdelFattah ME. Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Postoperative Mechanically Ventilated Children After Open Abdominal Surgeries: Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Jul 3;2025:9699738. doi: 10.1155/anrp/9699738. eCollection 2025.
PubMed 40642177
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06994273
- Acronym / sponsor ID
- 36264PR315/8/23
- Conditions
- Analgesic, Sedative, Fentanyl, Dexmedetomidine, Infusion, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 May 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.
This study aimed to compare the efficacy and safety of fentanyl versus dexmedetomidine infusion in this population.
Detailed description
Appropriate sedation and analgesia are essential components in the post-operative care of critically ill children in the pediatric intensive care unit (PICU), especially those who need mechanical ventilation.
Fentanyl is an opioid analgesic that is 50-100 times more potent than morphine. It is used frequently because of its ability to provide rapid analgesia. A single dose of fentanyl significantly reduced pain behaviors and changes in heart rate. It also increased the growth hormone level.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with significant sedative and analgesic effects. Some studies have investigated its role in adult and pediatric intensive care, as a primary sedative or a second line following failure of benzodiazepines or opioid sedation, as a bridge for extubation, for substance withdrawal, and to decrease intensive care unit (ICU) delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Experimental | Drug: FentanylPatients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 4 to 11 years.
- Both sexes.
- Children who required a minimum of 24 hrs of mechanical ventilation following open abdominal surgeries
Key exclusion criteria (5 listed)
- Patients with significant congenital anomalies.
- Chromosomal abnormalities.
- Neurologic conditions prohibiting sedation evaluation.
- Neuromuscular diseases.
- Those receiving neuromuscular blockers
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 |
|---|---|---|
| FentanylPatients received fentanyl as a 1 μg/kg bolus over 10 min, followed by a 1-5 μg/kg/hr intravenous infusion after 10-15 minutes. | Drug | Fentanyl group |
| DexmedetomidinePatients received dexmedetomidine as a 1 μg/kg bolus over 10 min, followed by a 0.2-0.7 μg/kg/hr intravenous infusion after 10-15 minutes. | Drug | Dexmedetomidine group |
Primary outcome
Weaning eligibility
Time frame: 48 hours postoperatively
The time from ventilator weaning eligibility was monitored until discharge.
3 secondary outcomes
Time from eligibility to extubation
Time frame: 60 min postoperatively
Mean arterial pressure
Time frame: 48 hours post-infusion initiation
Heart rate
Time frame: 48 hours post-infusion initiation
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 29 May 2025.
- Derived from this study: PubMed 40642177Abotaleb AM, Elsheikh MR, Elshimy KM, AbdelFattah ME. Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Postoperative Mechanically Ventilated Children After Open Abdominal Surgeries: Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Jul 3;2025:9699738. doi: 10.1155/anrp/9699738. eCollection 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Analgesic
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
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 and Dexmedetomidine in people with Analgesic and Sedative, run by Tanta 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 3 inclusion and 5 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 29 May 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.
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?
Weaning eligibility (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994273, which also lists 1 linked publication.
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 29 May 2025.