Ketamine in Post-operative Dental Pain and Recovery

NCT02021240 | Completed Phase 3

• 1 other identifier: UW13-525
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Pain scores as numerical rating scale after operation

  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

  Before operation and at post-operative day1 and day 2

• Number of patients having adverse effects

  Postoperative day 1 to day 3

• Serum IL-6 and TNF - α

  Before operation and at postoperative 6th and 16th hour

Study Arms (3)

Ketamine

ACTIVE COMPARATOR

Single dose of intravenous ketamine 0.5mg/kg before incision

Drug: Ketamine

Dexamethasone

ACTIVE COMPARATOR

Single dose of intravenous dexamethasone 8mg before incision

Drug: Dexamethasone

Normal saline

PLACEBO COMPARATOR

Single dose of intravenous normal saline before incision

Drug: Normal Saline

Interventions

Ketamine DRUG

Ketamine

Dexamethasone DRUG

Dexamethasone

Normal Saline DRUG

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chi Wai Cheung

  Department of Anaesthesiology, Queen Mary Hospital, Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 27, 2013
• Study Start: February 10, 2014
• Primary Completion: September 18, 2015
• Study Completion: April 18, 2016
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

HK (1)