Postoperative Pain
Conditions
Keywords
Tonsillectomy, Postoperative Pain, Clonidine, Anesthetics, Local
Brief summary
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).
Detailed description
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).
Interventions
DRUGlidocaine (1%) + bupivacaine (0.5%)
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%)
DRUGNormal saline
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline
DRUGLidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 3 - 17 years old * BMI \< 35 * Negative pregnancy test in female patients age 10 and older * Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy
Exclusion criteria
* Diagnosis of obstructive sleep apnea * Patient with peritonsillar abscess * Allergy to study medication * Any major systemic illness, genetic disorder or diagnosed syndrome * Bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Post-operative Doses of Analgesics. | Post-operative thru day 7 | The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Time Until Discharge From Hospital. | Day of Surgery | — |
| Mean Visual Analog Scale Pain Number. | in recovery room; post-operative days 1,3,5 & 7 | Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever |
| Median Number of Pain Medication Doses | in recovery room | The median number of intravenous fentanyl doses administered in the PACU due to pain |
| Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-operative days 1,3,5 & 7. | 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 |
| Number and Percent of Participants Able to Tolerate a Regular Diet | post-operative days 1,3,5 & 7. | The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7 |
| Number and Percent of Participants Able to Tolerate Only Liquids | post-operative days 1,3,5 & 7. | The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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%) | 40 |
| 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) | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Incomplete Data | 4 | 3 | 3 |
| Overall Study | Injection performed after tonsillectomy | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Normal Saline | Lidocaine (1%) + Bupivacaine 0.5% | Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Total |
|---|---|---|---|---|
| Age, Continuous | 6 years | 7 years | 8 years | 7 years |
| Region of Enrollment United States | 40 participants | 40 participants | 40 participants | 120 participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 23 Participants | 67 Participants |
| Sex: Female, Male Male | 16 Participants | 20 Participants | 17 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 4 / 40 | 6 / 40 | 6 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
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)
Time frame: Post-operative thru day 7
Population: Number of patients randomized to each group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normal Saline | Total Number of Post-operative Doses of Analgesics. | 12 number of doses |
| Lidocaine (1%) + Bupivacaine 0.5% | Total Number of Post-operative Doses of Analgesics. | 12 number of doses |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Total Number of Post-operative Doses of Analgesics. | 14 number of doses |
Secondary
Mean Visual Analog Scale Pain Number.
Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever
Time frame: in recovery room; post-operative days 1,3,5 & 7
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Normal Saline | Mean Visual Analog Scale Pain Number. | day 1 | 3 pain score |
| Normal Saline | Mean Visual Analog Scale Pain Number. | day 5 | 3 pain score |
| Normal Saline | Mean Visual Analog Scale Pain Number. | In recovery room | 3 pain score |
| Normal Saline | Mean Visual Analog Scale Pain Number. | day 3 | 3 pain score |
| Normal Saline | Mean Visual Analog Scale Pain Number. | day 7 | 2.5 pain score |
| Lidocaine (1%) + Bupivacaine 0.5% | Mean Visual Analog Scale Pain Number. | day 3 | 2.5 pain score |
| Lidocaine (1%) + Bupivacaine 0.5% | Mean Visual Analog Scale Pain Number. | day 7 | 2 pain score |
| Lidocaine (1%) + Bupivacaine 0.5% | Mean Visual Analog Scale Pain Number. | day 5 | 2 pain score |
| Lidocaine (1%) + Bupivacaine 0.5% | Mean Visual Analog Scale Pain Number. | day 1 | 4 pain score |
| Lidocaine (1%) + Bupivacaine 0.5% | Mean Visual Analog Scale Pain Number. | In recovery room | 3 pain score |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Mean Visual Analog Scale Pain Number. | day 7 | 2 pain score |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Mean Visual Analog Scale Pain Number. | In recovery room | 3 pain score |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Mean Visual Analog Scale Pain Number. | day 1 | 5 pain score |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Mean Visual Analog Scale Pain Number. | day 3 | 3 pain score |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Mean Visual Analog Scale Pain Number. | day 5 | 3 pain score |
Secondary
Median Number of Pain Medication Doses
The median number of intravenous fentanyl doses administered in the PACU due to pain
Time frame: in recovery room
Population: per group doses
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normal Saline | Median Number of Pain Medication Doses | 3.0 number of doses |
| Lidocaine (1%) + Bupivacaine 0.5% | Median Number of Pain Medication Doses | 3 number of doses |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Median Number of Pain Medication Doses | 3 number of doses |
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
Time frame: post-operative days 1,3,5 & 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Saline | Number and Percent of Participants Able to Tolerate a Regular Diet | post-op day 1 | 7 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate a Regular Diet | post op day 7 | 24 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate a Regular Diet | post op day 5 | 21 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate a Regular Diet | post-op day 3 | 18 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate a Regular Diet | post-op day 3 | 8 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate a Regular Diet | post op day 5 | 18 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate a Regular Diet | post op day 7 | 26 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate a Regular Diet | post-op day 1 | 4 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate a Regular Diet | post op day 7 | 22 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate a Regular Diet | post-op day 1 | 1 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate a Regular Diet | post op day 5 | 14 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate a Regular Diet | post-op day 3 | 12 Participants |
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
Time frame: post-operative days 1,3,5 & 7.
Population: per group diet
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Saline | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-op day 1 | 26 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post op day 7 | 13 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post op day 5 | 13 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-op day 3 | 18 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-op day 3 | 26 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post op day 5 | 17 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-op day 1 | 22 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post op day 7 | 10 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-op day 1 | 26 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post-op day 3 | 18 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post op day 5 | 18 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only a Soft Diet | post op day 7 | 14 Participants |
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
Time frame: post-operative days 1,3,5 & 7.
Population: per group data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Saline | Number and Percent of Participants Able to Tolerate Only Liquids | post-op day 1 | 16 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate Only Liquids | post-op day 3 | 8 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate Only Liquids | post op day 5 | 13 Participants |
| Normal Saline | Number and Percent of Participants Able to Tolerate Only Liquids | post op day 7 | 6 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only Liquids | post op day 7 | 11 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only Liquids | post-op day 1 | 33 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only Liquids | post op day 5 | 10 Participants |
| Lidocaine (1%) + Bupivacaine 0.5% | Number and Percent of Participants Able to Tolerate Only Liquids | post-op day 3 | 13 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only Liquids | post op day 7 | 10 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only Liquids | post-op day 3 | 23 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only Liquids | post op day 5 | 19 Participants |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Number and Percent of Participants Able to Tolerate Only Liquids | post-op day 1 | 30 Participants |
Secondary
Total Time Until Discharge From Hospital.
Time frame: Day of Surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normal Saline | Total Time Until Discharge From Hospital. | 122 minutes |
| Lidocaine (1%) + Bupivacaine 0.5% | Total Time Until Discharge From Hospital. | 111 minutes |
| Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg | Total Time Until Discharge From Hospital. | 120 minutes |