Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy

Children, Only Clinical Trial

Official title:

Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902314
• Other study ID #: 014118
• Status: Completed
• Phase: Phase 4
• Start date: May 7, 2019
• Est. completion date: December 6, 2021

Study information

• Verified date: December 2021
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lidocaine is widely available and is a very commonly used local anesthetic. When administered intravenously, lidocaine infusions have anti-inflammatory effects and have significantly decreased the reliance on opioid use for adequate pain management in adult abdominal and spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a significant side effect profile.The role of lidocaine in pediatric acute perioperative pain remains limited.

Description:

The aim of the study is to determine if using lidocaine continuously during anesthesia care will decrease post-operative pain for children having their tonsils and adenoids removed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital

Exclusion Criteria:

• history of allergies to local anesthetics

• physical or developmental delays

• psychiatric illness

• current use of sedative or anticonvulsive medications

• use of premedication (oral/nasal)

• pre-existing cardiovascular, renal, or hepatic disease

• pre-existing cerebral or neuromuscular disease

• patient with personal or family history of malignant hyperthermia

• recent history of upper respiratory infection within last 7 days

• regular use of analgesic medications

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Children, Only
• Hypertrophy
• Tonsillar Hypertrophy

Intervention

Drug:
• Lidocaine Iv
Intravenous infusion
• Saline Solution
Intravenous infusion

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Guntinas-Lichius O, Volk GF, Geissler K, Komann M, Meissner W. Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2049-60. doi: 10.1007/s00405-014-2914-9. Epub 2014 Feb 9. — View Citation

Howard D, Davis KF, Phillips E, Ryan E, Scalford D, Flynn-Roth R, Ely E. Pain management for pediatric tonsillectomy: an integrative review through the perioperative and home experience. J Spec Pediatr Nurs. 2014 Jan;19(1):5-16. doi: 10.1111/jspn.12048. Epub 2013 Aug 21. Review. — View Citation

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. — View Citation

Vigneault L, Turgeon AF, Côté D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Scores	FLACC scale includes 5 categories (Face, Legs, Activity, Cry, Consolability) of pain behaviors scored from 0-2 to provide a total pain score ranging from 0 to 10 with higher numbers indicating greater or worse pain.	15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.
Secondary	Opioid consumption	Morphine equivalents	Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU)
Secondary	Emergence delirium scores	Pediatric Anesthesia Emergence Delirium (PAED) scale to differentiate emergence delirium from postoperative pain. The scale includes 5 categories (eye contact, purposefulness of actions, awareness of surroundings, restlessness, inconsolable) each scored from 0 to 4 to provide a total score ranging from 0 to 20 with higher numbers being worse indicating that the emergence behaviors correlate better with emergence delirium.	5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery
Secondary	Parental satisfaction with the anesthetic	Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better	Evaluated once on postoperative day 1 (or 24 hours after surgery)