Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02021240 |
| Other study ID # |
UW13-525 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2014 |
| Est. completion date |
April 18, 2016 |
Study information
| Verified date |
November 2020 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
