Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children

NCT04535089 | Completed Phase 1

• 1 other identifier: 6318
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future. Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Intraoperative total fentanyl consumption.

  Intraoperative fentanyl 0.5ug/ kg when the heart rate and mean arterial blood pressure of patients increased \> 20% from basal measurement after exclusion of other causes.

  from induction till end of surgery up to 3 hours intraoperative.

Secondary Outcomes (6)

• pain intensity

  immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative.

• level of sedation

  up to one hour postoperative

• Time to first call for rescue analgesic (fentanyl)

  up to one hour postoperative

• Total amount of nalbuphine consumption

  up to twelve hours postoperative

• The duration of Post Anesthesia Care Unite stay

  up to 2 hour postoperative

Study Arms (2)

dexmedetomdine

ACTIVE COMPARATOR

IV bolus dose of 0.5ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5ug/kg/h

Drug: Dexmedetomidine injection

lidocaine

ACTIVE COMPARATOR

IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h

Drug: Lidocaine Iv

Interventions

Dexmedetomidine injection DRUG

receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h

Also known as: precedex

dexmedetomdine

Lidocaine Iv DRUG

IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h

Also known as: xylocaine 1%

lidocaine

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 6-18 years old.
• Sex: both sexes.
• Physical status: American Society Of Anesthesiologist 1\& II.
• Body Mass Index \>5 th and \< the 85th percentile for age.
• Type of operations: elective intracranial surgeries under general anesthesia.
• Duration of operation \< 3 hours.
• Written informed consent from the parent of child

You may not qualify if:

• Altered mental state
• Unsuitability for extubation.
• Patients on beta blocker, alpha 2 agonist.
• Patients on pain killer or with known history of allergy to study drugs.
• Hepatic, renal, Cardiovascular and respiratory disease.
• The patient has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of medicine

Zagazig, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alshaimaa Kamel, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anaesthesia ,and surgical intensive care

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: September 1, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-12

Locations

EG (1)