Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery

NCT03261921 | Completed Phase 1

• 1 other identifier: N-43-2016
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

Conditions

Caudal Block

Outcome Measures

Primary Outcomes (2)

• Time of first request of analgesia

  the time from caudal block to the first time to analgesic needs

  12 hours

• pain scores

  the modified objective pain score

  12 hours

Secondary Outcomes (3)

• sedation score

  12 hours

• heart rates(beat/minute)

  3 hours.

• mean arterial pressure (mmhg)

  3 hours

Study Arms (3)

Dexamethasone group

ACTIVE COMPARATOR

In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.

Drug: Dexamethasone; Drug: Bupivacaine

Dexmedetomidine group

ACTIVE COMPARATOR

In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.

Drug: Dexmedetomidine; Drug: Bupivacaine

Combination group

ACTIVE COMPARATOR

In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.

Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: Bupivacaine

Interventions

Dexamethasone DRUG

Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs

Also known as: decadron

Combination group; Dexamethasone group

Dexmedetomidine DRUG

Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics

Also known as: precedex

Combination group; Dexmedetomidine group

Bupivacaine DRUG

local anesthetic agent

Also known as: plain marcaine

Combination group; Dexamethasone group; Dexmedetomidine group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Gender Eligibility Details: males candidate for hypospadias surgery
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for hypospadias surgery

You may not qualify if:

• Contraindication to caudal anesthesia.
• cardiovascular diseases.
• drug allergy.
• Type I diabetes.
• Clotting disorders.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Patients allocated to study groups using computer generated random list \& group assignment was sealed in sequentially numbered opaque envelopes that opened after induction of anesthesia.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator,MD of anesthesia and intensive care unit.

Model Details: Sixty-three patients with ASA I-II aged from 1-6 years scheduled for hypospadias surgery in Abu El-Resh pediatric Hospital-Cairo university, were included in this prospective randomized double-blinded clinical study. Patients with contraindication to caudal anesthesia, cardiovascular diseases, drug allergy, type I diabetes, clotting disorders, mentally retarded children or those whose families did not approve inclusion in the study were excluded from the study. Patients were randomly divided on the morning of surgery into three groups group I( dexamethasone 21 patients), Group II ( Dexmedetomidine 21 patients) and group III(Dexmedetomidine and dexamethasone 21 patients).

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 25, 2017
• Study Start: June 5, 2016
• Primary Completion: June 22, 2017
• Study Completion: July 7, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share