NCT05902780

Brief 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). 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Sep 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Sep 2024Oct 2027

First Submitted

Initial submission to the registry

May 23, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

May 23, 2023

Last Update Submit

February 12, 2024

Conditions

AnesthesiaLocal Anesthesia

Keywords

AnesthesiaCaudalEpiduralRegionalpostoperative pain

Outcome Measures

Primary Outcomes (3)

  • Amount of opioids needed by patients.

    How much opioids in mcg/kg will the patient needs

    Intraoperative (during the surgery)

  • Amount of opioids needed by patients.

    How much opioids in mcg/kg will the patient needs

    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

    during the first 6 hours postoperative

Secondary Outcomes (4)

  • Blood pressure

    Preoperative,Intraoperative and 2 hours postoperative

  • Heart rate

    Preoperative, intraoperative, and 2 hours postoperative

  • Emergence agitation

    Intraoperative with extubation

  • Presence of respiratory depression

    2 hours Postoperative every 10 min

Study Arms (2)

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.

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.

Drug: Caudal Dexmedetomidine Injection

Interventions

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.

Group B (25 patients)
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.

Group D (25 patients)

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia at Faculty of Medicine, Benha University

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 15, 2023

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 13, 2024

Record last verified: 2024-02