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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Dexmedetomidine injection; Drug: Lidocaine Iv

Detailed Description

Site of study:

This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals.

b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University, Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dexmedetomdine; 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; 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; Other Names: precedex
ACTIVE_COMPARATOR: lidocaine; IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h	Drug: Lidocaine Iv; IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h; Other Names: xylocaine 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	In the Post Anesthesia Care Unite( PACU), the intensity of pain will be assessed using The Wong-Baker Faces Pain Rating Scale (WBFPS) . The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". The child is instructed to choose the face that best describes their intensity of pain currently being experienced immediately on arrival to PACU, and at 5, 10, 15 mintues till the child will be discharge from PACU. The child will be ready for discharge from PACU when attained an Aldrete score ≥9 and free from pain, nausea and vomiting. Protocol for pain management, IV paracetamol 15mg/kg every 6h. maximum daily dose 60mg/kg not exceeding 2grams. Child with WBFPS score > 4 will be treated with nalbuphine 0.1mg/kg as rescue analgesic	immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative.
level of sedation	Assessment of level of sedation by 6-point Pediatric Sedation State Scale (PSSS) in the PACU :The six activity states are as follows: State 5: Movement impedes procedure and requires forceful immobilization State 4: Movement requires gentle immobilization for positioning State 3: Facial expression of pain or anxiety State 2: Quiet, not moving, no frown, no verbalization of complaint (ideal state) State 1: Deeply asleep with normal vital signs, but requires airway intervention or assistance (e.g., central or obstructive apnea) State 0: Deeply asleep with abnormal physiologic parameters that require acute intervention (e.g., O2 saturation <90%, hypotension, bradycardia).	up to one hour postoperative
Time to first call for rescue analgesic (fentanyl)	Child with Wong-Baker Faces Pain Rating Scale (WBFPS) score > 4 will be treated with nalbuphine0.1 mg/kg as rescue analgesic as rescue analgesic. The Wong-Baker Faces Pain Rating Scale (WBFPS) . The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". The child is instructed to choose the face that best describes their intensity of pain currently being experienced	up to one hour postoperative
Total amount of nalbuphine consumption	Total amount of nalbuphine consumption in the first 12 hour postoperative	up to twelve hours postoperative
The duration of Post Anesthesia Care Unite stay	The child will be ready for discharge from PACU to word when attained modified Aldrete score ≥9, fully conscious and no complaint of pain.	up to 2 hour postoperative
side-effects	side- effects including hypotension MAP < 60, bradycardia HR < 60b/m.	up to 12 hour postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): September 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: 6318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No