Post-operative PainPhase 3NCT02021240
Ketamine in Post-operative Dental Pain and Recovery
A Phase 3 study testing Ketamine, Dexamethasone and Normal Saline in people with Post-operative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Ketamine, Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Feb 2014to 18 Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II
- Bilateral wisdom teeth extraction under general anaesthesia
- Age over 18
- Written informed consent
Who cannot join
- Allergy to ketamine or dexamethasone
- Patient refusal
- Pregnancy
- Alcohol or drug abuse
- Known impaired renal function and liver function
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong
Hong Kong, 0000
About this study
Official title: Effects of Ketamine in Post-operative Pain and Recovery Outcomes in Bilateral Third Molar Surgery Under General Anaesthesia
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.
Read more
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.
Read the 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.
- Conditions
- Post-operative Pain
- Being tested
- Ketamine, Dexamethasone, Normal Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
DexamethasoneDrug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Single dose of intravenous ketamine 0.5mg/kg before incision Receives: Drug: Ketamine |
| Dexamethasone | Active comparator | Single dose of intravenous dexamethasone 8mg before incision Receives: Drug: Dexamethasone |
| Normal saline | Placebo comparator | Single dose of intravenous normal saline before incision Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores as numerical rating scale after operation
Measured: 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 outcomes (3)
Facial oedema measured by using 3D laser scanning of the face
Measured: Before operation and at post-operative day1 and day 2
Number of patients having adverse effects
Measured: Postoperative day 1 to day 3
Serum IL-6 and TNF - α
Measured: Before operation and at postoperative 6th and 16th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start10 Feb 2014
- Primary completion18 Sep 2015
- Study completion18 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chi-Wai Cheung, The University of Hong Kong
- Investigators
- Chi Wai Cheung, Study director, Department of Anaesthesiology, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021240
- Sponsor's protocol ID
- UW13-525
- Status last verified
- Nov 2020
- First submitted
- 11 Dec 2013
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketamine in Post-operative Pain and Recovery Outcomes in Bilateral Third Molar Surgery Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT02021240
- Acronym / sponsor ID
- UW13-525
- Conditions
- Post-operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 18 Sep 2015 (actual)
- Study completion
- 18 Apr 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 |
|---|---|---|
| Ketamine | Active comparator | Drug: KetamineSingle dose of intravenous ketamine 0.5mg/kg before incision |
| Dexamethasone | Active comparator | Drug: DexamethasoneSingle dose of intravenous dexamethasone 8mg before incision |
| Normal saline | Placebo comparator | Drug: Normal SalineSingle dose of intravenous normal saline before incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I and II
- Bilateral wisdom teeth extraction under general anaesthesia
- Age over 18
- Written informed consent
Key exclusion criteria (5 listed)
- Allergy to ketamine or dexamethasone
- Patient refusal
- Pregnancy
- Alcohol or drug abuse
- Known impaired renal function and liver function
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 |
|---|---|---|
| Ketamine | Drug | Ketamine |
| Dexamethasone | Drug | Dexamethasone |
| Normal Saline | Drug | Normal saline |
Primary outcome
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
3 secondary outcomes
Facial oedema measured by using 3D laser scanning of the face
Time frame: Before operation and at post-operative day1 and day 2
Number of patients having adverse effects
Time frame: Postoperative day 1 to day 3
Serum IL-6 and TNF - α
Time frame: Before operation and at postoperative 6th and 16th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
Chi Wai Cheung study director
Department of Anaesthesiology, Queen Mary Hospital, Hong Kong
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 Ketamine, Dexamethasone and Normal Saline in people with Post-operative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 9 Nov 2020. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.