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

Zagazig University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Analgesia

Treatments

Drug: Lidocaine Iv

Drug: Dexmedetomidine injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04535089

6318

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

6 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.