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The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Following intraoperative IV placement, a 1.5 mg/kg bolus does of lidocaine hydrochloride is given and is followed by a continuous infusion of 2 mg/kg/hr until discharge from the Phase 1 recovery period. |
|
| Placebo | Placebo Comparator | Following intraoperative IV placement, a bolus of saline is given and is followed by a continuous infusion until discharge from the Phase 1 recovery period. The volume of the bolus and rate of infusion are equivalent to that which would have been given in the experimental arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observer Rated Pain Intensity | Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals. | Within the immediate post-operative period (90 minutes after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Rated Pain Intensity | 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. | Within the immediate post-operative period (90 minutes after surgery) |
| Observer Rated Emergence Delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert Benzon, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26184397 | Background | Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2. | |
| 10692621 | Background |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Saline | Drug | Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period. |
|
|
Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals. |
| Within the immediate post-operative period (90 minutes after surgery) |
| Observer Rated PACU Discharge Criteria | Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals. | Within the immediate post-operative period (90 minutes after surgery) |
| Parent Rated Postoperative Pain at Home | 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. | Every day, up to 7 days postoperatively |
| Medication Journal | Parents will keep a journal of all pain medication given to their children to treat pain. | Every day, up to 7 days postoperatively |
| Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000 Mar;85(1-2):217-24. doi: 10.1016/s0304-3959(99)00268-7. |
| 23595509 | Background | Goldman JL, Baugh RF, Davies L, Skinner ML, Stachler RJ, Brereton J, Eisenberg LD, Roberson DW, Brenner MJ. Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention. Laryngoscope. 2013 Oct;123(10):2544-53. doi: 10.1002/lary.23926. Epub 2013 Apr 17. |
| 20518581 | Background | McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000. |
| 41134317 | Derived | Benzon HA, King MR, Kilner KJ, Shah RD, Billings KR, Hoff SR, McCarthy RJ. Intravenous Lidocaine for Postoperative Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial. Anesth Analg. 2026 Jul 1;143(1):122-131. doi: 10.1213/ANE.0000000000007786. Epub 2025 Oct 23. |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |