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The effectiveness of pregabalin for post-tonsillectomy pain control

Status Approved

First Submitted Date

2014/08/11
Registered Date

2014/08/27
Last Updated Date

2015/06/25

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001215
Unique Protocol ID	OC10MISE0025
Public/Brief Title	The effectiveness of pregabalin for post-tonsillectomy pain control
Scientific Title	The effectiveness of pregabalin for post-tonsillectomy pain control
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	OC10MISE0025
Approval Date	2010-06-02
Institutional Review Board Name	Institutional Review of Board of Incheon St Mary's hospital, college of medicine, the catholic university of korea
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Soo Seog Park
Title	Associate professor
Telephone
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address
Contact Person for Public Queries
Name	Dong Hyun Kim
Title	Assistant professor
Telephone
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address
Contact Person for Updating Information
Name	Dong Hyun Kim
Title	Assistant professor
Telephone
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2010-12-10 Actual
Target Number of Participant	80
Primary Completion Date	2012-08-03 , Actual
Study Completion Date	2012-12-25 , Actual
Name of Study	The Catholic University of Korea, Incheon St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2010-12-10 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	The Catholic University of Korea, Incheon St. Mary's Hospital
Organization Type	Medical Institute
Project ID	OC10MISE0025

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Incheon St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Tonsillectomy is one of the most common surgical procedures performed in otorhinolaryngology. However, postoperative pain following tonsillectomy is one of the most difficult to manage in this area of surgery. The severe pain from a tonsillectomy can delay the recovery process and extend the hospital stay. Therefore, various analgesics and a number of surgical techniques have been suggested to improve pain relief. Opioids or nonsteroidal anti-inflammatory drugs (NSAIDs) and local anesthesia have been used exclusively or in combination. However, opioids can cause respiratory depression, bradycardia, hypoxia, nausea, and vomiting; NSAIDs can increase the risk of bleeding in the operated area; and local anesthesia can cause toxic reactions and upper airway closures. Therefore, there is a need for a new approach that can control the pain after a tonsillectomy while reducing the use of opioids and NSAIDs. Recent advances in the pathophysiology of pain have suggested that it is possible to prevent or attenuate the central neural hyperexcitability that contributes to enhanced postoperative pain. Pregabalin is a novel anticonvulsant drug that has demonstrated analgesic effects in acute postoperative pain management. Jokela et al. reported that perioperative administration of 600 mg pregabalin decreases oxycodone consumption compared with administration of 10 mg diazepam, but is associated with an increased incidence of adverse effects. However, there are few studies of the effectiveness of premedication with pregabalin for post-tonsillectomy pain control compared with an active placebo, such as diazepam, to exclude the effects of sedation or dizziness. Therefore, this study was conducted to evaluate the effectiveness of pregabalin premedication compared with diazepam as an active placebo on postoperative pain control after tonsillectomy.

Study Summary Information

Lay Summary

Tonsillectomy is one of the most common surgical procedures performed in otorhinolaryngology. However, postoperative pain following tonsillectomy is one of the most difficult to manage in this area of surgery. The severe pain from a tonsillectomy can delay the recovery process and extend the hospital stay. Therefore, various analgesics and a number of surgical techniques have been suggested to improve pain relief. Opioids or nonsteroidal anti-inflammatory drugs (NSAIDs) and local anesthesia have been used exclusively or in combination. However, opioids can cause respiratory depression, bradycardia, hypoxia, nausea, and vomiting; NSAIDs can increase the risk of bleeding in the operated area; and local anesthesia can cause toxic reactions and upper airway closures. Therefore, there is a need for a new approach that can control the pain after a tonsillectomy while reducing the use of opioids and NSAIDs.
Recent advances in the pathophysiology of pain have suggested that it is possible to prevent or attenuate the central neural hyperexcitability that contributes to enhanced postoperative pain. Pregabalin is a novel anticonvulsant drug that has demonstrated analgesic effects in acute postoperative pain management. Jokela et al. reported that perioperative administration of 600 mg pregabalin decreases oxycodone consumption compared with administration of 10 mg diazepam, but is associated with an increased incidence of adverse effects. However, there are few studies of the effectiveness of premedication with pregabalin for post-tonsillectomy pain control compared with an active placebo, such as diazepam, to exclude the effects of sedation or dizziness. Therefore, this study was conducted to evaluate the effectiveness of pregabalin premedication compared with diazepam as an active placebo on postoperative pain control after tonsillectomy.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	Prior to surgery, we explained the goal of this study to all patients, who were then educated in the use of the visual analogue scale (VAS) chart and the use of a patient-controlled analgesia (PCA) pump. The night before and 1 hour before surgery each patient received either a 150 mg capsule of pregabalin (total 300 mg before surgery) (Lyrica, Freiburg, Germany) or a 2 mg capsule of diazepam orally (total 4 mg before surgery). General anesthesia was induced with intravenous propofol (2 mg/kg) and tracheal intubation was facilitated with intravenous rocuronium bromide (0.6 mg/kg). Anesthesia was maintained with sevoflurane and 50% nitrous oxide in oxygen. Paralysis was reversed with glycopyrrolate and pyridostigmine at the end of surgery. Tonsillectomy was performed using the same technique for all patients, including monopolar electrocautery; bleeding was controlled using simple compression, bipolar electrocautery, and topical application of hydrogen peroxide. As a basic analgesic regimen, both groups were given acetaminophen 650 mg three times daily (total 1950 mg per day) for 8 postoperative days. While in the hospital, patients in both groups were supplied with 1% fentanyl that was administered via a PCA device (Abbott Aim PlusTM, Abbott Laboratories, Illinois) with the same parameters (demand dose = 2 ml, lockout time = 10 min, no basal infusion), and the total amount of injected fentanyl was recorded before discharge. Additionally, 30 mg of ketorolac tromethamine was injected intramuscularly at the patient’s request, and the number of ketorolac tromethamine injections was recorded.
Number of Arms	2
Arm 1	Arm Label Diazepam group
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description The night before and 1 hour before surgery each patient received a 2 mg capsule of diazepam orally (total 4 mg before surgery)
Arm 2	Arm Label pregabalin group
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description The night before and 1 hour before surgery each patient received a 150 mg capsule of pregabalin (total 300 mg before surgery)

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J03.90)Acute tonsillitis, unspecified, not specified as recurrent
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description Patients over the age of 18 years who were scheduled for elective tonsillectomy at our hospital during the period between December 2010 and August 2012 were enrolled in this study.
Exclusion Criteria	1.allergy to drugs in the study, 2. alcohol or drug abuse, 3. treatment with antidepressant or antiepileptic medication within 4 weeks of the operation, 4. pregnant or breastfeeding patients, 5. tonsillar malignancy, 6. impaired kidney function, or 7. daily intake of analgesics or intake of any analgesic within 24 hours of surgery
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	patient-controlled fentanyl consumption
Timepoint	from 0 to 24 hours after tonsillectomy
Secondary Outcome(s) 1
Outcome	the number of ketorolac tromethamine injections
Timepoint	from 0 to 24 hours after tonsillectomy
Secondary Outcome(s) 2
Outcome	postoperative pain score at rest and swallowing
Timepoint	1, 2, 4, 8, 12, and 24 hours postoperatively, and then daily for 7 days after discharge
Secondary Outcome(s) 3
Outcome	the overall satisfaction score
Timepoint	24 hours after surgery and on the eighth postoperative day
Secondary Outcome(s) 4
Outcome	occurrence of side effects such as drowsiness, nausea, dizziness, headache, and vomiting.
Timepoint	from 0 to 24 hours after tonsillectomy

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Published
Final Enrollment Number
Number of Publication	1
Publications 1	Soo Seog Park, Dong-Hyun Kim, In-Chul Nam, Il-Whan Lee, Jae-Woong Hwang. The effectiveness of Pregabalin for Post-Tonsillectomy Pain Control: A Randomized Controlled Trial. PLoS One. Non SCI. 2015-02-01 , VOL : 10 page : ~
Results Upload
Date of Posting Results	2014/08/27
Protocol URL or File Upload
Brief Summary

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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