AnesthesiaNCT05902780
Can Caudal Dexmedetomidine Provide Effective Analgesia?
A study testing Caudal Bupivacaine injection and Caudal Dexmedetomidine Injection in people with Anesthesia and Local Anesthesia, run by Benha University.
Trial summary
The goal of this clinical trial is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics, if used caudally alone (and not as an adjunct to caudal bupivacaine). Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Anesthesia, Local Anesthesia
- What is being tested?
- Caudal Bupivacaine injection and Caudal Dexmedetomidine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA-I and ASA-II pediatric patients (age :1-6 years old)
- Inguinoscrotal surgeries
Who cannot join
- Patient's parent's refusal
- Unable to give consent
- Known allergy to the study medications
- Coagulopathies or on anticoagulant medications
- ASA-III or ASA-IV
About this study
Official title: Can Caudal Dexmedetomidine Provide Effective Analgesia During Pediatric Inguinoscrotal Surgery?
The goal of this clinical trial is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics, if used caudally alone (and not as an adjunct to caudal bupivacaine).
The main question it aims to answer is:
- Can caudal dexmedetomidine provide effective analgesia? Participants will be pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries.
- A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups:
- Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg.
- Group D (n =25): In this group, and after injection of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
Read the detailed description
- Introduction
- Caudal anesthesia is a relatively low-risk technique commonly used, either on its own or in combination with sedation or general anesthesia.
- Caudal anesthesia is one of the most used-popular regional blocks in children. This technique is a useful adjunct during general anesthesia and for providing postoperative analgesia after infra-umbilical operations.
- Caudal blocks performed on sedated children, enable not only early ambulation, but also periprocedural hemodynamic stability and spontaneous breathing in patient groups at maximum risk of a difficult airway. These are important advantages over general anesthesia, notably in preterm babies and in children with cardiopulmonary co-morbidities. Caudal epidural anesthesia has been shown to reduce stress response and shorten the time for extubation in children.
- Caudal anesthesia is indicated for surgical and non-surgical painful interventions in body areas from the sub-umbilical region downwards. Examples include procedures such as inguinal hernia repair, cystoscopy/transurethral manipulation, circumcision, anal atresia, treatment of limb ischemia, treatment of intussusception, or cast application to immobilize newborns with hip dysplasia.
- Contraindications to caudal anesthesia in children would include local site infection, pilonidal cyst, or spinal dysraphism such as tethered cord syndrome.
- Bupivacaine (an amide local anesthetic) has provided reliable anesthesia and analgesia.
- Bupivacaine is the indicated local anesthetic in caudal, epidural, and spinal anesthesia and is widely used clinically to manage acute and chronic pain. In addition to blocking Na+ channels, bupivacaine affects the activity of many other channels, including NMDA receptors.
- Adverse effects of bupivacaine includes local anesthetic systemic toxicity, urinary retention, high block, hypotension, delayed respiratory depression, and cardiac arrest.
- Dexmedetomidine is an alpha agonist having sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties. It produces these effects by inhibiting central sympathetic outflow by blocking the alpha receptors in the brainstem, thereby inhibiting the release of norepinephrine.
- Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, which binds to transmembrane G protein-binding adrenoreceptors in the periphery (α2A), brain, and spinal cord (α2B, α2C) tissues.
In contrast to other sedative agents, dexmedetomidine, by acting on α2 receptors in the locus caeruleus, has potential analgesic effects without respiratory depression.
- Dexmedetomidine seems to help to reduce the time for extubation.
- Dexmedetomidine is also an adjunct infusion during general anesthesia. There is evidence that dexmedetomidine decreases postoperative pain, postoperative opioid usage, and nausea. This effect has also been shown to be present when using dexmedetomidine for sedation during procedures performed under spinal anesthesia. There has been some interest in using dexmedetomidine as an adjunct to prevent emergence agitation, postoperative delirium, and postoperative cognitive dysfunction. There is evidence for the prevention of emergence agitation in both children and adults.
- The most common adverse effects of dexmedetomidine are hypotension and bradycardia which result from the stimulation of presynaptic alpha receptors, which leads to a decreased release of norepinephrine; this is in addition to the decrease in the central sympathetic outflow. These are concerns regardless of the route of administration.
Ethical consideration :
The study protocol will be approved by the Institutional Research Ethics Committee. Informed written consent will be obtained from all parents of the pediatric patients, after being explained the purpose of the study and will be ensured strict confidentiality. They will be given the option of not participating in the study if they do not want to.
Type and design of the study:
- Study population: The study will be conducted at Benha University Surgical Hospital starting from July 2023 on pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries.
- Study design: Randomized prospective single-blind study.
- Sample size calculation The sample size was calculated using Power and Sample Size software version 3 based on a previous study, which explore the analgesic effect of caudal dexmedetomidine versus caudal morphine if used as an adjunct to bupivacaine in pediatric infra-umbilical surgery. The total sample size calculated was 50 patients (25 patients in each group).
- Methods:
A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups:
Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg Group D (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
- Aim of the work: The main objective of our study is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics.
- Conditions
- Anesthesia, Local Anesthesia
- Being tested
- Caudal Bupivacaine injection, Caudal Dexmedetomidine Injection
- Keywords
- Anesthesia, Caudal, Epidural, Regional, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Bupivacaine injectionDrug
- Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg.
Caudal Dexmedetomidine InjectionDrug
- Group D (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Group B (25 patients) | Active comparator | In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg. Receives: Drug: Caudal Bupivacaine injection |
| Group D (25 patients) | Active comparator | In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg. Receives: Drug: Caudal Dexmedetomidine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of opioids needed by patients.
How much opioids in mcg/kg will the patient needs
Measured: Intraoperative (during the surgery)
Amount of opioids needed by patients.
How much opioids in mcg/kg will the patient needs
Measured: during the first 6 hours postoperative
Time to the first analgesic rescue
Measure time in minutes (min) till the patient needs opioids for the first time postoperative
Measured: during the first 6 hours postoperative
Secondary outcomes (4)
Blood pressure
Measure blood pressure in mmHg of the patient every 10 min
Measured: Preoperative,Intraoperative and 2 hours postoperative
Heart rate
Measure heart rate in beat/min every 10 min
Measured: Preoperative, intraoperative, and 2 hours postoperative
Emergence agitation
The incidence of emergence agitation is high in children, the level of agitation will be assessed through Paediatric Anesthesia Emergence Delirium Scale (PAED SCALE) which consist of 5 criteria that are scored using 5-point scale. The scores of each criterion are added to make a total score. The maximum achieved score is 20.
Measured: Intraoperative with extubation
Presence of respiratory depression
Measure respiratory rate in breath/ min
Measured: 2 hours Postoperative every 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Elsayed Mohamed Amer, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902780
- Sponsor's protocol ID
- Dexmedetomidine
- Status last verified
- Feb 2024
- First submitted
- 23 May 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Caudal Dexmedetomidine Provide Effective Analgesia During Pediatric Inguinoscrotal Surgery?
- ClinicalTrials.gov ID
- NCT05902780
- Acronym / sponsor ID
- Dexmedetomidine
- Conditions
- Anesthesia, Local Anesthesia
- Keywords
- Anesthesia, Caudal, Epidural, Regional, postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Jun 2023 (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 goal of this clinical trial is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics, if used caudally alone (and not as an adjunct to caudal bupivacaine).
The main question it aims to answer is:
- Can caudal dexmedetomidine provide effective analgesia? Participants will be pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries.
- A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups:
- Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg.
- Group D (n =25): In this group, and after injection of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
Detailed description
- Introduction
- Caudal anesthesia is a relatively low-risk technique commonly used, either on its own or in combination with sedation or general anesthesia.
- Caudal anesthesia is one of the most used-popular regional blocks in children. This technique is a useful adjunct during general anesthesia and for providing postoperative analgesia after infra-umbilical operations.
- Caudal blocks performed on sedated children, enable not only early ambulation, but also periprocedural hemodynamic stability and spontaneous breathing in patient groups at maximum risk of a difficult airway. These are important advantages over general anesthesia, notably in preterm babies and in children with cardiopulmonary co-morbidities. Caudal epidural anesthesia has been shown to reduce stress response and shorten the time for extubation in children.
- Caudal anesthesia is indicated for surgical and non-surgical painful interventions in body areas from the sub-umbilical region downwards. Examples include procedures such as inguinal hernia repair, cystoscopy/transurethral manipulation, circumcision, anal atresia, treatment of limb ischemia, treatment of intussusception, or cast application to immobilize newborns with hip dysplasia.
- Contraindications to caudal anesthesia in children would include local site infection, pilonidal cyst, or spinal dysraphism such as tethered cord syndrome.
- Bupivacaine (an amide local anesthetic) has provided reliable anesthesia and analgesia.
- Bupivacaine is the indicated local anesthetic in caudal, epidural, and spinal anesthesia and is widely used clinically to manage acute and chronic pain. In addition to blocking Na+ channels, bupivacaine affects the activity of many other channels, including NMDA receptors.
- Adverse effects of bupivacaine includes local anesthetic systemic toxicity, urinary retention, high block, hypotension, delayed respiratory depression, and cardiac arrest.
- Dexmedetomidine is an alpha agonist having sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties. It produces these effects by inhibiting central sympathetic outflow by blocking the alpha receptors in the brainstem, thereby inhibiting the release of norepinephrine.
- Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, which binds to transmembrane G protein-binding adrenoreceptors in the periphery (α2A), brain, and spinal cord (α2B, α2C) tissues.
In contrast to other sedative agents, dexmedetomidine, by acting on α2 receptors in the locus caeruleus, has potential analgesic effects without respiratory depression.
- Dexmedetomidine seems to help to reduce the time for extubation.
- Dexmedetomidine is also an adjunct infusion during general anesthesia. There is evidence that dexmedetomidine decreases postoperative pain, postoperative opioid usage, and nausea. This effect has also been shown to be present when using dexmedetomidine for sedation during procedures performed under spinal anesthesia. There has been some interest in using dexmedetomidine as an adjunct to prevent emergence agitation, postoperative delirium, and postoperative cognitive dysfunction. There is evidence for the prevention of emergence agitation in both children and adults.
- The most common adverse effects of dexmedetomidine are hypotension and bradycardia which result from the stimulation of presynaptic alpha receptors, which leads to a decreased release of norepinephrine; this is in addition to the decrease in the central sympathetic outflow. These are concerns regardless of the route of administration.
Ethical consideration :
The study protocol will be approved by the Institutional Research Ethics Committee. Informed written consent will be obtained from all parents of the pediatric patients, after being explained the purpose of the study and will be ensured strict confidentiality. They will be given the option of not participating in the study if they do not want to.
Type and design of the study:
- Study population: The study will be conducted at Benha University Surgical Hospital starting from July 2023 on pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries.
- Study design: Randomized prospective single-blind study.
- Sample size calculation The sample size was calculated using Power and Sample Size software version 3 based on a previous study, which explore the analgesic effect of caudal dexmedetomidine versus caudal morphine if used as an adjunct to bupivacaine in pediatric infra-umbilical surgery. The total sample size calculated was 50 patients (25 patients in each group).
- Methods:
A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups:
Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg Group D (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
- Aim of the work: The main objective of our study is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B (25 patients) | Active comparator | Drug: Caudal Bupivacaine injectionIn this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg. |
| Group D (25 patients) | Active comparator | Drug: Caudal Dexmedetomidine InjectionIn this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA-I and ASA-II pediatric patients (age :1-6 years old)
- Inguinoscrotal surgeries
Key exclusion criteria (5 listed)
- Patient's parent's refusal
- Unable to give consent
- Known allergy to the study medications
- Coagulopathies or on anticoagulant medications
- ASA-III or ASA-IV
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 |
|---|---|---|
| Caudal Bupivacaine injection- Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg. | Drug | Group B (25 patients) |
| Caudal Dexmedetomidine Injection- Group D (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg. | Drug | Group D (25 patients) |
Primary outcome
Amount of opioids needed by patients.
Time frame: Intraoperative (during the surgery)
How much opioids in mcg/kg will the patient needs
Amount of opioids needed by patients.
Time frame: during the first 6 hours postoperative
How much opioids in mcg/kg will the patient needs
Time to the first analgesic rescue
Time frame: during the first 6 hours postoperative
Measure time in minutes (min) till the patient needs opioids for the first time postoperative
4 secondary outcomes
Blood pressure
Time frame: Preoperative,Intraoperative and 2 hours postoperative
Heart rate
Time frame: Preoperative, intraoperative, and 2 hours postoperative
Emergence agitation
Time frame: Intraoperative with extubation
Presence of respiratory depression
Time frame: 2 hours Postoperative every 10 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Bupivacaine injection and Caudal Dexmedetomidine Injection in people with Anesthesia and Local Anesthesia, run by Benha University.
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 2 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: opening soon, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Amount of opioids needed by patients. (time frame: Intraoperative (during the surgery)). The study lists 3 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 13 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.