Pain
Conditions
Brief summary
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.
Detailed description
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo. Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.
Interventions
DRUGLidocaine
Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.
DRUGSaline
Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital * American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)
Exclusion criteria
* Physical or developmental delays * Psychiatric illness * Current use of sedative or anticonvulsant medications * Pre-existing renal disease (ranging from stage 2 \[mild\] to stage 5 \[end stage\]) * Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia) * Pre-existing liver disease * Pre-existing cerebral or neuromuscular disease * Patient or family history of Malignant Hyperthermia * Recent history of upper respiratory infection within last 7 days * Regular use of analgesic medication * Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation * Other procedure scheduled in addition to tonsillectomy * History of allergies to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observer Rated Pain Intensity | Within the immediate post-operative period (90 minutes after surgery) | Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Journal | Every day, up to 7 days postoperatively | Parents will keep a journal of all pain medication given to their children to treat pain. |
| Patient Rated Pain Intensity | Within the immediate post-operative period (90 minutes after surgery) | Patient Rated Pain Intensity will be measured using the Faces Pain Scale - Revised (FPS-R) by pointing to pictures of faces displaying a spectrum of pain at regular 5 and 15 minute time intervals. |
| Observer Rated Emergence Delirium | Within the immediate post-operative period (90 minutes after surgery) | Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals. |
| Observer Rated PACU Discharge Criteria | Within the immediate post-operative period (90 minutes after surgery) | Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals. |
| Parent Rated Postoperative Pain at Home | Every day, up to 7 days postoperatively | Parent Rated Postoperative Pain at Home will be measured using the Parents Postoperative Pain Measures (PPPM) questionnaire and Numerical Rating Scale to report on the intensity of their child's pain. |
Countries
United States
Outcome results
None listed