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Can Caudal Dexmedetomidine Provide Effective Analgesia?

ConditionsAnesthesiaLocal Anesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA-I and ASA-II pediatric patients (age :1-6 years old)

Inguinoscrotal surgeries

Disqualifiers

Patient's parent's refusal

Unable to give consent

Known allergy to the study medications

Coagulopathies or on anticoagulant medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caudal Bupivacaine injection

    Drug

    \- 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 Injection

    Drug

    \- 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group B (25 patients)Active comparator 1 intervention
Group B: Group D (25 patients)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Amount of opioids needed by patients.

How much opioids in mcg/kg will the patient needs

Time frame
Intraoperative (during the surgery)
2

Amount of opioids needed by patients.

How much opioids in mcg/kg will the patient needs

Time frame
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

Time frame
during the first 6 hours postoperative

Secondary outcomes

1

Blood pressure

Measure blood pressure in mmHg of the patient every 10 min

Time frame
Preoperative,Intraoperative and 2 hours postoperative
2

Heart rate

Measure heart rate in beat/min every 10 min

Time frame
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.

Time frame
Intraoperative with extubation
4

Presence of respiratory depression

Measure respiratory rate in breath/ min

Time frame
2 hours Postoperative every 10 min

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: