NCT02496299

Brief Summary

It is a prospective double blind randomized study on the effect of dexamethasone added to bupivacaine with plain bupivacaine for caudal block in patient for herniotomy. 96 patients between the ages 1-6 years will be randomly selected and divided into two groups; B and BD. Group B will receive 1ml/kg bupivacaine 0.25% (maximum volume 20mls) and group BD will receive a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine 0.25% (maximum volume = 20mls). Data taken will then be analyzed and interpreted.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

July 5, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

July 5, 2015

Last Update Submit

July 13, 2015

Conditions

Caudal Block

Keywords

COMPARISSONCAUDAL BLOCKBUPIVACAINEDEXAMETHASONE

Outcome Measures

Primary Outcomes (1)

  • time to first analgesic requirement

    defined as the time from the caudal injection till the first rescue analgesia was administered (Modified Objective Pain Score, mOPS score of 4 or more).

    within the first 24 hours post operatively

Secondary Outcomes (1)

  • the number of oral paracetamol

    required in the first 24 hours post operatively

Other Outcomes (3)

  • Postoperative pain will be assessed using a modified Objective Pain Score (mOPS) every 30 min for the first 2 h and at 4, 6, 8, 10, 12, 18, and 24 h postoperatively

    within 24 hours

  • Motor block will be assessed using a modified Bromage scale consisting of four points [0 = full motor strength (flexion of knees and feet), 1 = flexion of knees, 2 = little movement of feet only, 3 = no movement of knees or feet

    within 24 hours

  • The sedation score will; be assessed using a four-point scale (1, alert and aware; 2, asleep, arousable by verbal contact; 3, asleep, arousable by physical contact; and 4, asleep, not arousable).

    within 24 hours

Study Arms (2)

dexametasone (BD),

ACTIVE COMPARATOR

BD ,a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine

Drug: Dexamethasone

Bupivacaine,B

ACTIVE COMPARATOR

B ,1ml/kg bupivacaine:

Drug: Bupivacaine

Interventions

DexamethasoneDRUG

Comparison of analgesic effects of dexamethasone with plain bupivacaine during caudal blocks in children

Also known as: STEROID,LOCAL ANAEDSTHETIC
dexametasone (BD),
BupivacaineDRUG

Comparison of analgesic effects of dexamethasone with plain bupivacaine during caudal blocks in children

Also known as: heavy marcaine
Bupivacaine,B

Eligibility Criteria

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

You may qualify if:

  • Patients aged 1-6 years, classified as American Society of Anesthesiologist (ASA) 1 and 11 who are undergoing herniotomy and whose parents or legal guardian has duly signed an informed consent form.

You may not qualify if:

  • Patients with hypersensitivity to any local anesthetics
  • Children with Bleeding diathesis
  • Presence of Infections at puncture sites
  • Preexisting neurological disease
  • Patients with diabetes mellitus
  • Failure to consent by parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexamethasoneSteroidsBupivacaine

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • FAGBOHUN A OMOLOLA, MBBS

    SCHOOL OF ANAESTHETIC STUDIES BADAGRY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FAGBOHUN A OMOLOLA, MBBS

CONTACT

234-8023005881lolafagbohun@yahoo.com

AKANDE A ABDULRASHEED, BSc

CONTACT

234-8056403088kolakande24@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 5, 2015

First Posted

July 14, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07