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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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.
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 groups in NCT05902780
Study groupRoleWhat they receive
Group B (25 patients)Active comparatorIn 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 comparatorIn 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.

  1. Amount of opioids needed by patients.

    How much opioids in mcg/kg will the patient needs

    Measured: Intraoperative (during the surgery)

  2. Amount of opioids needed by patients.

    How much opioids in mcg/kg will the patient needs

    Measured: during the first 6 hours postoperative

  3. 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)
  1. Blood pressure

    Measure blood pressure in mmHg of the patient every 10 min

    Measured: Preoperative,Intraoperative and 2 hours postoperative

  2. Heart rate

    Measure heart rate in beat/min every 10 min

    Measured: Preoperative, intraoperative, and 2 hours postoperative

  3. 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

  4. 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.

  1. First posted15 Jun 2023
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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)
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

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.

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