Caudal Dexmedetomidine Analgesia in Pediatrics .

February 26, 2021 updated by: Mohamed Abd Latif Ghanim, Mansoura University

The Analgesic Effectiveness and Safety of Upgraded Caudal Dexmedetomidine Doses in Pediatric Hypospadias Surgery.

Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression).The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.

Optimal effective dose defined as; the least caudal DEXM dose which produce the best analgesic outcome [least time to 1st analgesic request and lowest rescue analgesic dose (24Hs)] associated with the least stress response (cortisol PO. first One hour peak), least PO sedation, and hemodynamic stability IO. &PO. HR & MAP. The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour.

. Material & Methods A prospective randomized double blinded (drug injector and PO assessor) comparative study will be conducted in Mansoura university hospital after obtaining ethics committee approval and written informed parental consent 164 boys (age 1-6 years, ASA I) scheduled for hypospadias surgery. Exclusion criteria; (Operative time exceeding 3 hours, bodyweight >25kg, bleeding diathesis, infection at the site of block, pre-existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study. Patients will fast for solids 6h and water and 2 hours before surgery. After Patient Preoperative preparation, General anesthesia induction, caudal block and caudal drug injection (Levob plus DEXM) bolus will be injected according to each group as follow;

  • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/kg.
  • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.
  • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/kg.
  • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.

The study outcomes recording:

1ry outcome: Time to (1st analgesic request OPS >4). Secondary outcome: Total 24hours PO. Rescue analgesic dose IM pethidine 0.5mg/kg [2,3] based on local policy and protocol, Patients demographic data [age, weight, end tidal Sevoflurane (volume %) prior starting skin closure, intraoperative fentanyl total dose, recovery time (time from discontinuation of anesthesia to spontaneous eye opening)], Serum Cortisol level at basal before anesthesia and 1hour postoperative in between groups [1] , Apnea incidence (NO&%), and desaturation (NO&%), Objective pain score, Sedation score, Behavioral score for Agitation assessment, and Modified bromage score (residual Lower limb muscle weakness) recorded every 15 minutes for 1st hour then every 30 minutes for next 3 PO hours then at next 6th, 12th, 18th, 24th PO hours, hemodynamics, HR&SBP the incidence of bradycardia and hypotension per 50% percentile. Recorded every 10 minutes IO for maximum operative time 3 hours and every 30 min PO for next 2h in the recovery room until the child was discharged to the ward.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Anesthesia department,Faculty of medicine, Mansoura univerisety

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 164 boys (age 1-8 years, ASA I) scheduled for hypospadias surgery

Exclusion Criteria:

  • Operative time exceeding 3 hours, bodyweight >25kg, bleeding diathesis, infection at the site of block, pre-existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k
Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.
Active Comparator: • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.
Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.
Active Comparator: • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/
Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.
Active Comparator: • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.
Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to (1st analgesic request objective pain score (OPS) ≥4)
Time Frame: Basal (0) till 24 hours.
time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose
Basal (0) till 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: mohamed A Ghanem, A professor, Mansoura Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

December 29, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFM IR.18.11.322 - 2018/11/11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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