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Completed

NCT Number: NCT04535089

Opioid Sparing Analgesia: 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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zagazig University, Faculty of medicine

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: precedex

Lidocaine IV

Drug

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

Other names: xylocaine 1%

Primary outcomes

  1. Intraoperative total fentanyl consumption.

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

    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.

Secondary outcomes

  1. pain intensity

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

    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

  2. level of sedation

    Time frame: up to one hour postoperative

    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).

  3. Time to first call for rescue analgesic (fentanyl)

    Time frame: up to one hour postoperative

    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

  4. Total amount of nalbuphine consumption

    Time frame: up to twelve hours postoperative

    Total amount of nalbuphine consumption in the first 12 hour postoperative

  5. The duration of Post Anesthesia Care Unite stay

    Time frame: up to 2 hour postoperative

    The child will be ready for discharge from PACU to word when attained modified Aldrete score ≥9, fully conscious and no complaint of pain.

  6. side-effects

    Time frame: up to 12 hour postoperative

    side- effects including hypotension MAP < 60, bradycardia HR < 60b/m.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2020
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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