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
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.
- 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