NCT04700228

Brief Summary

Various methods are used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus. This study is to compare two doses of Dexmedetomidine added as adjunct to local anaesthesia using reduced dose in caudal block for prolonging the duration of analgesia. Our secondary outcomes will include blood pressure, heart rate, urinary retention, nausea and vomiting in the paediatric population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 6, 2021

Last Update Submit

January 6, 2021

Conditions

Pain, Postoperative

Keywords

Postoperative painRegional AnaesthesiaCaudal BlockDexmedetomidineInfraumbilical surgeries

Outcome Measures

Primary Outcomes (5)

  • Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    1 hour after caudal block

  • Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    2 hours after caudal block

  • Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    4 hours after caudal block

  • Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    6 hours after caudal block

  • Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    12 hours after caudal block

Secondary Outcomes (15)

  • Heart Rate (bradycardia)

    1 hour after caudal block.

  • Heart Rate (bradycardia)

    2 hours after caudal block.

  • Heart Rate (bradycardia)

    4 hours after caudal block.

  • Heart Rate (bradycardia)

    6 hours after caudal block.

  • Heart Rate (bradycardia)

    12 hours after caudal block.

  • +10 more secondary outcomes

Study Arms (3)

Group C

PLACEBO COMPARATOR

0.25% bupivacaine at a total volume of 0.5ml/kg.

Drug: Bupivacaine Hydrochloride

Group BD1

ACTIVE COMPARATOR

0.25% bupivacaine + 1mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.

Drug: Bupivacaine HydrochlorideDrug: Dexmedetomidine

Group BD2

ACTIVE COMPARATOR

0.25% bupivacaine + 0.5mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.

Drug: Bupivacaine HydrochlorideDrug: Dexmedetomidine

Interventions

Bupivacaine HydrochlorideDRUG

We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.

Group BD1Group BD2Group C
DexmedetomidineDRUG

We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.

Group BD1Group BD2

Eligibility Criteria

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

You may qualify if:

  • American Society of Anaesthesiologists (ASA) Status I and II
  • Aged between 1 to 6 years
  • Planned for below umbilicus elective surgery

You may not qualify if:

  • Refusal to consent by parent/guardian
  • Injection site infection
  • Coagulation disorders
  • Congenital abnormalities of lower spine and meninges
  • Anticipated difficult airway requiring endotracheal intubation and intermittent positive pressure ventilation
  • Prone position surgical procedures
  • Known drug allergy history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Haris Chohan

Karachi, Sindh, 75400, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineDexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Haris Chohan, FCPS Pakistan

    Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences Karachi, Pakistan

    PRINCIPAL INVESTIGATOR

  • Syed Farjad Sultan, FCARCSI, PhD

    Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences Karachi, Pakistan

    PRINCIPAL INVESTIGATOR

  • Arun Kumar, FCPS

    Dr. Ruth KM Pfau Civil Hospital, Dow University of Health Sciences, Karachi, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Factorial Assignment Anesthesia will be induced with 100% oxygen and sevoflurane 8%. Once achieving the desired depth of anesthesia, I/V access will be taken. Propofol 3mg/kg and Nalbuphine 0.1mg/kg will be given. LMA of desirable size will be placed. After this, patient would be placed in lateral position for caudal Block. After all aseptic measures, Caudal Block procedure will be done with help of 23G needle by anatomical landmarks. On negative aspiration of the syringe, one of the drug combinations as explained under 'arms and intervention' will be used for the caudal block. First surgical incision will be given 10 mins after the application of caudal block. After the completion of surgery, LMA will be removed once the patient is awake and the patient will be shifted to PACU. IV paracetamol 15mg/kg will be given if FLACC score is more than 4 at any point during the surgery.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Member

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

PA(1)