Dexmedetomidine InfusionNCT04331418
Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery
A study testing Dexmedetomidine and caudal block in people with Dexmedetomidine Infusion and Pediatric, run by Tanta University at 1 site in Egypt.
Trial summary
Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Read more about this study
- Who is it for?
- Ages 2 to 12 years, men only
- Conditions the study is for
- Dexmedetomidine Infusion, Pediatric, Hypospadias Repair Surgery
- What is being tested?
- Dexmedetomidine and caudal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2020to 31 Oct 2020
- 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 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- male children
- american society of aneasthesia physical status grade I \&II
- patients aged from 2 years to 12 years
- patients will undergoing hypospadias repair surgery
Who cannot join
- history or evidence of infection at the back
- allergy to the study drugs
- bleeding/coagulation disorder
- developmental delay
- septic patients
- neurological or spinal diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence.
Various multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge.
Read more
In our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia.
Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers.
It also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus
- Being tested
- Dexmedetomidine, caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr
caudal blockProcedure or surgery
After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | On arrival to operating room, Noninvasive monitors, such as electrocardiography, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), will be attached and baseline parameters such as heart rate, mean arterial pressure, and peripheral oxygen saturation will be recorded . General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), cis-atracurium 0.1 mg/kg iv, +/- fentanyl 1 mcg/kg iv. Trachea will be intubated with an appropriate sized, endotracheal tube and maintenance of anesthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC. Dexamethasone 0.15 mg/kg iv will be given as PONV prophylaxis. Increments of fentanyl 0.5 mcg/kg iv and cis-atracurium 0.03 mg/kg iv will be given according to hemodynamics and capnography. |
| caudal group | Experimental | After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine. Receives: Procedure: caudal block |
| dexmetomidine group | Experimental | Children in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery of the studied patients
quality of recovery of the studied patients using modified objective pain score
Measured: in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours
quality of recovery of the studied patients
change in quality of recovery of the studied patients using modified objective pain score
Measured: from discharge from PACU up to 6 hours in the surgical ward
Secondary outcomes (6)
concentration of required postoperative analgesic
concentration of postoperative analgesic
Measured: in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
concentration of required postoperative analgesic
concentration of required postoperative analgesic
Measured: from discharge from PACU up to 6 hours in the surgical ward
concentration of required postoperative sedation
concentration of required postoperative sedation
Measured: in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
concentration of required postoperative sedation
concentration of required postoperative sedation
Measured: from discharge from PACU up to 6 hours in the surgical ward
number of patients developed perioperative complications.
number of patients developed perioperative complications
Measured: in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
number of patients developed perioperative complications.
number of patients developed perioperative complications
Measured: from discharge from PACU up to 6 hours in the surgical ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start28 Mar 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexmedetomidine InfusionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Faheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331418
- Sponsor's protocol ID
- precedex infusion in pediatric
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2020
- Last updated
- 24 Nov 2023
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery
- ClinicalTrials.gov ID
- NCT04331418
- Acronym / sponsor ID
- precedex infusion in pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Mar 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 2 Apr 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.
Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence.
Various multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge.
In our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia.
Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers.
It also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –On arrival to operating room, Noninvasive monitors, such as electrocardiography, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), will be attached and baseline parameters such as heart rate, mean arterial pressure, and peripheral oxygen saturation will be recorded . General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), cis-atracurium 0.1 mg/kg iv, +/- fentanyl 1 mcg/kg iv. Trachea will be intubated with an appropriate sized, endotracheal tube and maintenance of anesthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC. Dexamethasone 0.15 mg/kg iv will be given as PONV prophylaxis. Increments of fentanyl 0.5 mcg/kg iv and cis-atracurium 0.03 mg/kg iv will be given according to hemodynamics and capnography. |
| caudal group | Experimental | Procedure: caudal blockAfter negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine. |
| dexmetomidine group | Experimental | Drug: DexmedetomidineChildren in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- male children
- american society of aneasthesia physical status grade I \&II
- patients aged from 2 years to 12 years
- patients will undergoing hypospadias repair surgery
Key exclusion criteria (6 listed)
- history or evidence of infection at the back
- allergy to the study drugs
- bleeding/coagulation disorder
- developmental delay
- septic patients
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 |
|---|---|---|
| Dexmedetomidine1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr | Drug | dexmetomidine group |
| caudal blockAfter negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine. | Procedure or surgery | caudal group |
Primary outcome
quality of recovery of the studied patients
Time frame: in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours
quality of recovery of the studied patients using modified objective pain score
quality of recovery of the studied patients
Time frame: from discharge from PACU up to 6 hours in the surgical ward
change in quality of recovery of the studied patients using modified objective pain score
6 secondary outcomes
concentration of required postoperative analgesic
Time frame: in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
concentration of required postoperative analgesic
Time frame: from discharge from PACU up to 6 hours in the surgical ward
concentration of required postoperative sedation
Time frame: in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
concentration of required postoperative sedation
Time frame: from discharge from PACU up to 6 hours in the surgical ward
number of patients developed perioperative complications.
Time frame: in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
number of patients developed perioperative complications.
Time frame: from discharge from PACU up to 6 hours in the surgical ward
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 24 Nov 2023.
- 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.
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 Dexmedetomidine and caudal block in people with Dexmedetomidine Infusion and Pediatric, 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 4 inclusion and 6 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 24 Nov 2023. 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?
quality of recovery of the studied patients (time frame: in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours). The study lists 2 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 24 Nov 2023.