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Ketamine in Post-operative Dental Pain and Recovery

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Ketamine
Dexamethasone
Normal Saline
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I and II
  • Bilateral wisdom teeth extraction under general anaesthesia
  • Age over 18
  • Written informed consent

Exclusion Criteria:

  • Allergy to ketamine or dexamethasone
  • Patient refusal
  • Pregnancy
  • Alcohol or drug abuse
  • Known impaired renal function and liver function

Sites / Locations

  • Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ketamine

Dexamethasone

Normal saline

Arm Description

Single dose of intravenous ketamine 0.5mg/kg before incision

Single dose of intravenous dexamethasone 8mg before incision

Single dose of intravenous normal saline before incision

Outcomes

Primary Outcome Measures

Pain scores as numerical rating scale after operation

Secondary Outcome Measures

Facial oedema measured by using 3D laser scanning of the face
Number of patients having adverse effects
Serum IL-6 and TNF - α

Full Information

First Posted
December 11, 2013
Last Updated
November 5, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02021240
Brief Title
Ketamine in Post-operative Dental Pain and Recovery
Official Title
Effects of Ketamine in Post-operative Pain and Recovery Outcomes in Bilateral Third Molar Surgery Under General Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2014 (Actual)
Primary Completion Date
September 18, 2015 (Actual)
Study Completion Date
April 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Low dose sub-anaesthetic dose of ketamine has been shown to reduce postoperative pain and analgesic consumption. However, due to the heterogeneous results, the standard dosing regimen has not been available. Recently, its effect in postoperative outcomes and the development of post-operative surgical pain has also been suggested. Ketamine has been shown to reduce post-operative early inflammation especially serum IL-6. Therefore, study in its effects in post- operative pain and outcomes due to inflammation is suggested. Only few clinical studies assessed post-operative pain are related to inflammation. Pain after third molar surgery is a good model of postoperative acute inflammatory pain. A previous study showed that there was no benefit to administer ketamine before or after oral surgery for pain relief. However, other studies demonstrated that ketamine used as sedative or local ketamine in third molar surgery could reduce postoperative dental pain, swelling and trismus. Postsurgical facial oedema is difficult to quantify accurately as it is three dimensional. Over the years, various measurement techniques have been tried to measure oedema objectively. These include direct linear measurement using tape or flexible rulers across fixed soft tissue landmarks, standardized stereophotographic measurements, computerized tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and three - dimensional (3D) laser scanning. Recently, three dimensional image reconstructions using a reversed engineering technique has been developed and is used in the manufacturing industry. This technology could be applied in a clinical setting for monitoring soft tissue changes. In this study, the investigators will aim to study the use of sub-anaesthetic dose of ketamine in post-operative dental pain and recovery outcomes. The investigators hypothesise that post-operative pain after Bilateral Third Molar under General Anaesthesia is less in patients receiving sub-anaesthetic does of ketamine before incision. The magnitude of this effect will be compared with a positive control group (dexamethasone) as well as a placebo group (normal saline). Further, the investigators aim to demonstrate whether ketamine can reduce post-operative facial oedema and other post-operative outcomes.
Detailed Description
3 groups: Ketamine group: • Patient will receive single dose of intravenous ketamine 0.5mg/kg before incision. Dexamethasone group: Patient will receive single dose of intravenous dexamethasone 8mg before incision Control group Patient will receive single dose of intravenous normal saline before incision. Process: After obtaining informed consent, patient will be randomly allocated to one of three groups. HADS and SF-36 questionnaires will be completed by the patients on admission. Blood for serum IL-6 and TNF - α will be taken. 3D laser scanning of the face will be performed. The patients will not receive any premedication and will follow other routine preoperative preparation. Patients will be educated to use the Numerical Pain Rating Scale for pain assessment, where 0= no pain and 10 the most severe pain. P deletion test and mini-mental test will be done at ward before operation. Before induction, ketamine 0.5mg/kg, dexamethasone 8mg or normal saline of same volume will be administrated intravenously according to the study group allocated. Induction of anaesthesia will be achieved according to a standard protocol. Regional block with 2% lignocaine with 1 in 80000 adrenaline will be performed by surgeon before start of the procedure. The surgery will be started once the anaesthesia is effective. The patients will be transferred to the recovery area for monitoring for at least 30 minutes postoperatively. The vital signs including blood pressure, pulse and SpO2 and the Ramsay sedation score (RSS) will be assessed every 5 minutes. Pain score (NRS) will be recorded every 15 minutes. The patients will be sent back to general ward when the parameters are normal. P deletion test will be done from postoperative hour 2 in the general ward until the performance is at least the same as that before operation. Mini-mental test will be done at 2 hours postoperatively. Hourly blood pressure, pulse, SpO2 and pain score (NRS) will be performed for 4 hours. Pain score (NRS) will be assessed 4 hourly afterward. Quality of recovery will be assessed after operation with Chinese QoR. Serum IL-6 and TNF-α will be taken at postoperative 6th hour and 16th hour. Paracetamol 1 g three times daily and tramadol 50mg three times daily as required will be prescribed postoperatively. The patients will be discharged home at postoperative day 1 if the discharge criteria are met. 3D laser scanning of the face will be performed before they are discharged. They will be asked the degree of satisfaction of the operation . Paracetamol 1 g three times daily and tramadol 50mg three times daily as required will be prescribed on discharge. A diary will be given to the patient. From postoperative day 1 to day 3, at each morning, average pain score (NRS), analgesic consumption and side effects will be marked on the diary by the patient. At the 3rd month after operation, the severity and nature of pain at the surgical sites will be asked over phone. The patients will be asked to go to the Oral & Maxillofacial Surgery out-patient clinic at the Prince Philip Dental Hospital on postoperative day 2 for 3D laser scanning of the face.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Single dose of intravenous ketamine 0.5mg/kg before incision
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Single dose of intravenous dexamethasone 8mg before incision
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Single dose of intravenous normal saline before incision
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
Pain scores as numerical rating scale after operation
Time Frame
Every 15 minutes for 1 hour after operation, every 4 hourly at the first 24 hour after operation, and at postoperative 48th and 72rd hour
Secondary Outcome Measure Information:
Title
Facial oedema measured by using 3D laser scanning of the face
Time Frame
Before operation and at post-operative day1 and day 2
Title
Number of patients having adverse effects
Time Frame
Postoperative day 1 to day 3
Title
Serum IL-6 and TNF - α
Time Frame
Before operation and at postoperative 6th and 16th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I and II Bilateral wisdom teeth extraction under general anaesthesia Age over 18 Written informed consent Exclusion Criteria: Allergy to ketamine or dexamethasone Patient refusal Pregnancy Alcohol or drug abuse Known impaired renal function and liver function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Wai Cheung
Organizational Affiliation
Department of Anaesthesiology, Queen Mary Hospital, Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

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Ketamine in Post-operative Dental Pain and Recovery

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