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Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsillar fossa prior to removal. While these studies have shown great promise, no large randomized trial of the most promising medications has been conducted. Because of this, many otolaryngologists do not administer intra-operative medications aimed at reducing post-operative pain. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | 1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy |
|
| Lidocaine (1%) + Bupivacaine 0.5% | Active Comparator | Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy |
|
| Lidocaine + Bupivacaine + Clondine | Experimental | Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine (1%) + bupivacaine (0.5%) | Drug | Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Post-operative Doses of Analgesics. | The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms) | Post-operative thru day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Number of Pain Medication Doses | The median number of intravenous fentanyl doses administered in the PACU due to pain | in recovery room |
| Total Time Until Discharge From Hospital. | Day of Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan R Moss, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Monroe Carrel Jr. Children's Hospital | Nashville | Tennessee | 37299 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17312203 | Background | Cucchiaro G, Ganesh A. The effects of clonidine on postoperative analgesia after peripheral nerve blockade in children. Anesth Analg. 2007 Mar;104(3):532-7. doi: 10.1213/01.ane.0000253548.97479.b8. | |
| 16159655 | Background | Naja MZ, El-Rajab M, Kabalan W, Ziade MF, Al-Tannir MA. Pre-incisional infiltration for pediatric tonsillectomy: a randomized double-blind clinical trial. Int J Pediatr Otorhinolaryngol. 2005 Oct;69(10):1333-41. doi: 10.1016/j.ijporl.2005.03.020. Epub 2005 Apr 22. |
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No plan to share unless specifically requested within 5 year storage of data period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline |
| FG001 | Lidocaine (1%) + Bupivacaine 0.5% | Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%) |
| FG002 | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline |
| BG001 | Lidocaine (1%) + Bupivacaine 0.5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Post-operative Doses of Analgesics. | The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms) | Number of patients randomized to each group | Posted | Median | Full Range | number of doses | Post-operative thru day 7 |
|
Each patient was followed for adverse events for the duration they were in the study and up to their post-operative visit at 3 weeks post-surgery.
We used the same definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | Normal Saline normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. A - normal saline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Moss MD | Charlotte Eye Ear Nose and Throat | 704-295-3000 | jmoss@ceenta.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal saline | Drug | Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline |
|
| Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) | Drug | Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg) |
|
| Mean Visual Analog Scale Pain Number. | Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever | in recovery room; post-operative days 1,3,5 & 7 |
| Number and Percent of Participants Able to Tolerate Only Liquids | The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7 | post-operative days 1,3,5 & 7. |
| Number and Percent of Participants Able to Tolerate Only a Soft Diet | The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7 | post-operative days 1,3,5 & 7. |
| Number and Percent of Participants Able to Tolerate a Regular Diet | The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7 | post-operative days 1,3,5 & 7. |
| 17720118 | Background | McCartney CJ, Duggan E, Apatu E. Should we add clonidine to local anesthetic for peripheral nerve blockade? A qualitative systematic review of the literature. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):330-8. doi: 10.1016/j.rapm.2007.02.010. |
| 8436459 | Background | Jebeles JA, Reilly JS, Gutierrez JF, Bradley EL Jr, Kissin I. Tonsillectomy and adenoidectomy pain reduction by local bupivacaine infiltration in children. Int J Pediatr Otorhinolaryngol. 1993 Jan;25(1-3):149-54. doi: 10.1016/0165-5876(93)90048-8. |
| 1784501 | Background | Jebeles JA, Reilly JS, Gutierrez JF, Bradley EL Jr, Kissin I. The effect of pre-incisional infiltration of tonsils with bupivacaine on the pain following tonsillectomy under general anesthesia. Pain. 1991 Dec;47(3):305-308. doi: 10.1016/0304-3959(91)90220-R. |
| 11587610 | Background | Giannoni C, White S, Enneking FK, Morey T. Ropivacaine with or without clonidine improves pediatric tonsillectomy pain. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1265-70. doi: 10.1001/archotol.127.10.1265. |
| 21422302 | Derived | Moss JR, Cofer S, Hersey S, Goudy S, Werkhaven J, Swanson E, Mantle C, Stowell N, Byrne D, Wang L, Labadie R. Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy. Arch Otolaryngol Head Neck Surg. 2011 Jun;137(6):591-7. doi: 10.1001/archoto.2011.45. Epub 2011 Mar 21. |
Lidocaine (1%) + Bupivacaine 0.5%
lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.
B - lidocaine (1%) + bupivacaine (0.5%)
| BG002 | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg) |
|
|
| Secondary | Median Number of Pain Medication Doses | The median number of intravenous fentanyl doses administered in the PACU due to pain | per group doses | Posted | Median | Full Range | number of doses | in recovery room |
|
|
|
| Secondary | Total Time Until Discharge From Hospital. | Posted | Median | Full Range | minutes | Day of Surgery |
|
|
|
| Secondary | Mean Visual Analog Scale Pain Number. | Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever | Posted | Mean | Full Range | pain score | in recovery room; post-operative days 1,3,5 & 7 |
|
|
|
| Secondary | Number and Percent of Participants Able to Tolerate Only Liquids | The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7 | per group data | Posted | Count of Participants | Participants | post-operative days 1,3,5 & 7. |
|
|
|
| Secondary | Number and Percent of Participants Able to Tolerate Only a Soft Diet | The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7 | per group diet | Posted | Count of Participants | Participants | post-operative days 1,3,5 & 7. |
|
|
|
| Secondary | Number and Percent of Participants Able to Tolerate a Regular Diet | The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7 | Posted | Count of Participants | Participants | post-operative days 1,3,5 & 7. |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | Lidocaine (1%) + Bupivacaine 0.5% | Lidocaine (1%) + Bupivacaine 0.5% lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. B - lidocaine (1%) + bupivacaine (0.5%) | 0 | 40 | 0 | 40 | 6 | 40 |
| EG002 | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg) | 0 | 40 | 0 | 40 | 6 | 40 |
| Emergency Department admission | General disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lingual nerve palsy | Nervous system disorders | Systematic Assessment |
|
| Severe pain | General disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| day 3 |
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| day 5 |
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| day 7 |
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| Title | Measurements |
|---|---|
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| post op day 5 |
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| post op day 7 |
|
| Title | Measurements |
|---|---|
|
| post op day 5 |
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| post op day 7 |
|
| Title | Measurements |
|---|---|
|
| post op day 5 |
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| post op day 7 |
|