PainPhase 2/3NCT02595463
Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients
A Phase 2/3 study testing Lidocaine and Saline in people with Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 5 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
Official title: Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine, Lidocaine Hydrochloride
Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.
SalineDrug
Also called Placebo
Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lidocaine |
| 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the immediate post-operative period (90 minutes after surgery)
Secondary outcomes (5)
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.
Measured: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated Emergence Delirium
Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every day, up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion5 Jun 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hubert Benzon, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Hubert Benzon, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595463
- Sponsor's protocol ID
- 2015-741
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2015
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26184397Koppert 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.
PubMed 10692621Goldman 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.
PubMed 23595509McCarthy 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.
PubMed 20518581Benzon 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.
PubMed 41134317
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02595463
- Acronym / sponsor ID
- 2015-741
- Conditions
- Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineFollowing 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 | Drug: SalineFollowing 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Xylocaine, Lidocaine HydrochlorideIntraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period. | Drug | Lidocaine |
| SalineAlso: PlaceboIntraoperative dose of saline followed by an infusion until discharge from the initial recovery period. | Drug | Placebo |
Primary outcome
Observer Rated Pain Intensity
Time frame: 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.
5 secondary outcomes
Patient Rated Pain Intensity
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated Emergence Delirium
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated PACU Discharge Criteria
Time frame: Within the immediate post-operative period (90 minutes after surgery)
Parent Rated Postoperative Pain at Home
Time frame: Every day, up to 7 days postoperatively
Medication Journal
Time frame: Every day, up to 7 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 26184397Kranke 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.
- Background: PubMed 10692621Koppert 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.
- Background: PubMed 23595509Goldman 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.
- Background: PubMed 20518581McCarthy 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.
- Derived from this study: PubMed 41134317Benzon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Benzon, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine and Saline in people with Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observer Rated Pain Intensity (time frame: Within the immediate post-operative period (90 minutes after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595463, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.