Postoperative PainPhase 3NCT00678379
Pediatric Tonsillectomy Pain Reduction Study
A Phase 3 study testing lidocaine (1%) + bupivacaine (0.5%), Normal saline and Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) in people with Postoperative Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- lidocaine (1%) + bupivacaine (0.5%), Normal saline and Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Diagnosis of obstructive sleep apnea
- Patient with peritonsillar abscess
- Allergy to study medication
- Any major systemic illness, genetic disorder or diagnosed syndrome
- Bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Monroe Carrel Jr. Children's Hospital
Nashville, Tennessee, 37299
About this study
Official title: Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics
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).
Read the 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).
- Conditions
- Postoperative Pain
- Being tested
- lidocaine (1%) + bupivacaine (0.5%), Normal saline, Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
- Keywords
- Tonsillectomy, Postoperative Pain, Clonidine, Anesthetics, Local
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%)
Normal salineDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | 1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy Receives: Drug: Normal saline |
| Lidocaine (1%) + Bupivacaine 0.5% | Active comparator | Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy Receives: Drug: lidocaine (1%) + bupivacaine (0.5%) |
| Lidocaine + Bupivacaine + Clondine | Experimental | Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy Receives: Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post-operative thru day 7
Secondary outcomes (6)
Median Number of Pain Medication Doses
The median number of intravenous fentanyl doses administered in the PACU due to pain
Measured: in recovery room
Total Time Until Discharge From Hospital.
Measured: Day of Surgery
Mean Visual Analog Scale Pain Number.
Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever
Measured: 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
Measured: 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
Measured: 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
Measured: post-operative days 1,3,5 & 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Moss, Vanderbilt University Medical Center
- Investigators
- Jonathan R Moss, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678379
- Sponsor's protocol ID
- 080127
- Status last verified
- Jun 2017
- First submitted
- 8 May 2008
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: No plan to share unless specifically requested within 5 year storage of data period.
Publications
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.
PubMed 17312203Naja 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.
PubMed 16159655McCartney 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.
PubMed 17720118Jebeles 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.
PubMed 8436459Jebeles 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.
PubMed 1784501Giannoni 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.
PubMed 11587610Moss 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.
PubMed 21422302
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Tonsillectomy Pain Reduction Study, a Randomized, Placebo Controlled, Double-Blind Clinical Trial Using Clonidine and Local Anesthetics
- ClinicalTrials.gov ID
- NCT00678379
- Acronym / sponsor ID
- 080127
- Conditions
- Postoperative Pain
- Keywords
- Tonsillectomy, Postoperative Pain, Clonidine, Anesthetics, Local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Normal saline1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy |
| Lidocaine (1%) + Bupivacaine 0.5% | Active comparator | Drug: lidocaine (1%) + bupivacaine (0.5%)Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy |
| Lidocaine + Bupivacaine + Clondine | Experimental | Drug: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Diagnosis of obstructive sleep apnea
- Patient with peritonsillar abscess
- Allergy to study medication
- Any major systemic illness, genetic disorder or diagnosed syndrome
- Bleeding disorder
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 |
|---|---|---|
| lidocaine (1%) + bupivacaine (0.5%)Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%) | Drug | Lidocaine (1%) + Bupivacaine 0.5% |
| Normal salineSubmucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline | Drug | Normal Saline |
| Lidocaine (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) | Drug | Lidocaine + Bupivacaine + Clondine |
Primary outcome
Total Number of Post-operative Doses of Analgesics.
Time frame: Post-operative thru day 7
The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)
6 secondary outcomes
Median Number of Pain Medication Doses
Time frame: in recovery room
Total Time Until Discharge From Hospital.
Time frame: Day of Surgery
Mean Visual Analog Scale Pain Number.
Time frame: in recovery room; post-operative days 1,3,5 & 7
Number and Percent of Participants Able to Tolerate Only Liquids
Time frame: post-operative days 1,3,5 & 7.
Number and Percent of Participants Able to Tolerate Only a Soft Diet
Time frame: post-operative days 1,3,5 & 7.
Number and Percent of Participants Able to Tolerate a Regular Diet
Time frame: post-operative days 1,3,5 & 7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17312203Cucchiaro 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.
- Background: PubMed 16159655Naja 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.
- Background: PubMed 17720118McCartney 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.
- Background: PubMed 8436459Jebeles 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.
- Background: PubMed 1784501Jebeles 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.
- Background: PubMed 11587610Giannoni 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.
- Derived from this study: PubMed 21422302Moss 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.
- Individual participant dataSharing planned: Undecided. No plan to share unless specifically requested within 5 year storage of data period.
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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.
Jonathan R Moss, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lidocaine (1%) + bupivacaine (0.5%), Normal saline and Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) in people with Postoperative Pain, run by Vanderbilt University Medical Center 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 4 inclusion and 5 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 2 Jul 2017. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Post-operative Doses of Analgesics. (time frame: Post-operative thru day 7). 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 NCT00678379, which also lists 7 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 2 Jul 2017.