NCT05790044

Brief Summary

Pain in children is usually an undertreated entity. Undertreating perioperative pain could lead to various metabolic, physiologic, and neurophysiological responses. The usual means of management i.e., opioids may increase the incidence of respiratory depression in this age group. Adequate postoperative analgesia in children is a vital part of perioperative care. Good pain relief minimizes oxygen requirement, reduces cardio-respiratory demands, and promotes early ambulation and recovery. Regional block given preoperatively in combination with general anesthesia provides good preemptive analgesia. It is associated with hemodynamic stability, rapid and complete recovery, and reduced analgesic requirement in postoperative period. Type of the study: A prospective randomized controlled double-blind study.

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
86

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable postoperative-pain

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

January 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

January 31, 2023

Last Update Submit

August 21, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score

    FLACC pain score as 1-3 = Mild discomfort; 4-6 = Moderate pain; 7-10 = Severe pain

    24 hours

Secondary Outcomes (4)

  • Heart Rate

    2 hours

  • Sedation Score

    6 hours

  • rescue analgesia

    24 hours

  • 5-point Likert scale Satisfaction Score

    24 hours

Study Arms (2)

Group Placebo

ACTIVE COMPARATOR

Children will receive intra-oral infra-orbital nerve block using bupivacaine 0.2% after induction of general anesthesia and before starting surgical procedure. Total volume of 1 ml each side.

Drug: Bupivacaine

Group Clonidine

ACTIVE COMPARATOR

Children will receive intra-oral infra-orbital nerve block using bupivacaine 0.2% and clonidine 1 ug/kg after induction of general anesthesia and before starting surgical procedure. Total volume of 1 ml each side.

Drug: Clonidine

Interventions

BupivacaineDRUG

intra-oral infra-orbital nerve block with bupivacaine alone

Group Placebo
ClonidineDRUG

intra-oral infra-orbital nerve block with bupivacaine and clonidine

Group Clonidine

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 1-7 years old.
  • Gender: both.
  • ASA physical status I-II
  • Children scheduled to undergo cleft lip revision surgeries.

You may not qualify if:

  • History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult.
  • Parents refusal.
  • Hypersensitivity to any local anesthetics.
  • Bleeding diathesis.
  • Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders.
  • Skin lesions or wounds at the puncture site of the proposed block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineClonidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ragaa Herdan, professor

    faculty of medicine assiut university egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ragaa Herdan, assis prof

CONTACT

01001741748ragaanesthesia@yahoo.com

Hany Ibrahem, professor

CONTACT

01005203980elmorabaa@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

March 29, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

March 1, 2025

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share