Does the sedative drug ketamine play a role in pain relief following wisdom teeth extractions?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Each patient would spend approximately 2 hours at the Oral and Maxillofacial surgery outpatient clinic at the Victoria General Hospital from pre‐operative assessment, undergoing surgery, and to discharge from the recovery room. Note that patients are expected to fast (nothing by mouth) for 8 hours prior to arriving for surgery. After registration of the participant’s information by the clinic receptionist (uninvolved in the study), the participant will visit the pre‐operative assessment nurse (also not related to the study). A standard pre‐operative history and physical would be performed and pre‐operative vitals would also be obtained at this time. This will include blood pressure, heart rate, oxygen saturation at room air, respiratory rate, and BMI. This process would take approximately 20‐30 minutes. The pre‐operative assessment nurse will verify the participant’s confirmation in the study but will not know if the patient will receive placebo or treatment of ketamine in the study. Pre‐operatively, the surgeon will randomly assign the patient to receive either ketamine or placebo by a simple coin toss (i.e. heads = ketamine, tails = placebo). For all participants, the medications used to induce PSA for the procedure will be midazolam and fentanyl. These medications will be given at standardized dosages as described below: Midazolam: Medication (in the form of a 1 mg/mL solution) to be administered via IV at 0.1 mg/kg per dose every 2 minutes to a maximum of 10 mg per surgery. The dosing increment will be titrated to achieve appropriate PSA effect. Fentanyl: Medication (in the form of a 100 mcg/ml solution) to be administered via IV at a rate of 0.5‐2 mcg/kg, and will increase in small increments at 2 minute intervals to a maximum of 100 mcg per surgery. The dosing increment will be titrated to achieve appropriate PSA effect. Placebo: Participants are administered 0.9% saline Ketamine: Participants are administered ketamine at a standardized sub‐anaesthetic dosa CONDITION: Wisdom teeth extractions ; Oral Health ; Wisdom teeth extractions PRIMARY OUTCOME: Degree of post‐operative pain experienced is assessed by use of a take‐home questionnaire containing multiple scales to describe the intensity of post‐operative pain experienced (from 0‐10, with 0 being no pain and 10 being most intense pain) at 6 hour intervals for up to 48 hours following wisdom teeth surgery SECONDARY OUTCOME: Use of pain medication (including type and dosage) is assessed by use of a take‐home questionnaire at 6 hour intervals for up to 48 hours following wisdom teeth surgery INCLUSION CRITERIA: 1. Male and female 2. Aged 16 to 25 years old 3. Health status is ASA I or ASA II 4. Presence of at least 3 wisdom teeth 5. Wisdom teeth present are associated with disease such as cavities or periodontal condition or 6. Wisdom teeth are impacted and will not predictably erupt functionally into the dentition
Epistemonikos ID: cd690a9f39e89fc0cb87e70cca9db78afcbb4daf
First added on: Aug 24, 2024