Health Condition 1: null- Patients on long term corticosteroids for conditions except for primary adrenal deficiency requiring dental procedures randomised to trial group or 1st control group as per study protocol.
Conditions
Interventions
Intervention1: 0.9% Normal Saline: 0.5 mL of 0.9% sterile normal sterile saline solution IV injection.
Control Intervention1: Hydrocortisone Succinate: 25 mg IV injection ( 0.5 mL of Hydrocortisone su
Sponsors
Principal Investigator self
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria For Control Group I and Interest Group: 1. Age: 18 years and older. 2. Under corticosteroid therapy for causes other than primary adrenal insufficiency 3. Receiving long term high dose corticosteroid supplementation, defined as average steroid dose of greater than or equal to 10 mg prednisone equivalent/day for period more than 3 months. 4. ASA Class I and ASA Class II 5. Requiring minor oral/dental surgical procedures under local anesthesia. For the purpose of the study the following minor oral surgical procedures as defined below are considered for inclusion: a) Elective dental extractions of 2 or more teeth in single appointment. b) Elective extraction or 1 or more teeth requiring reflection of gingiva with or without bone cutting. c) Elective alveoloplasty procedures involving 2 or more contiguous teeth regions. d) Elective alveoloplasty procedure involving two separate sites of any size in a single appointment. Inclusion Criteria for Control group II: 1. ASA Class I and II patients not classifiable under Control group II or Interest Group
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Fever of 100ââ?¬•F or more. 2. Features suggestive of adrenal insufficiency like weakness or fatigue, malaise, nausea, vomiting, diarrhoea, abdominal pain, headache (usually in morning), fever, anorexia or weight loss. 3. Suspected / proven space infections to be managed by incision and drainage / hospitalisation / IV antibiotics. 4. Pre-existing hyponatremia (less than 135 mEq/dL) during baseline measurement. 5. Patients with pre-existing hyperkalemia (more than 5 mEq/dL) during baseline measurement. 6. Patients with random capillary blood sugar more than 240 mg/dL on day of procedure. 7. Patients with increased blood urea nitrogen (BUN) (more than 40 mg/dL) 8. Patients with increased Serum Creatinine (more than 1.2 mg/dL) 9. Patient suspected or proven to be having sepsis. 10. Patient who are unstable or having uncontrolled disease process (For eg; uncontrolled diabetes, uncontrolled hypertension etc.,) 11. Patient with history of febrile illness of duration more than 3 days in past 2 months 12. Patients who have any specific contraindication to removal of teeth. 13. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome I: Hemodynamic changes among the groups measured by changes in mean arterial blood pressure, pulse pressure and heart rate. Primary Outcome II: Occurrence of clinically significant adverse events during the procedure, such as syncope, hypoglycemia, transient hypotension or any subjective feeling of unwellness in the study groups which are defined in the brief summary section of the protocol.Timepoint: 1. Baseline (primary outcome I) 2. 5 minutes prior to procedure on dental chair (primary outcome I & II) 3. 5 minutes after administering Local anesthesia (primary outcome I & II) 4. 5 minutes after end of procedure. (primary outcome I & II) 5. At 30 minutes, 60 minutes and 120 minutes after the procedure (primary outcome I & II) 6. Post discharge after 3 days upto 5 days by telephonic or in-person review, as per patients convenience (primary outcome II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of pre-procedural stress levels to occurrence of adverse events in the study groups. Pre-procedural stress will be measured as a continuous variable using the VAS scale of 100 mm line (without any markings on the scale visible to the participant) and the distance from zero point to patient marked point rounded off to nearest half a millimeter.Timepoint: 5 minutes prior to starting the procedure after patient has been seated in the dental chair for the procedure.;Procedural pain will be measured as a continuous variable using the VAS scale of 100 mm line (without any markings on the scale visible to the participant) and the distance from zero point to patient marked point rounded off to nearest half a millimeter.Timepoint: Immediately after the end of the procedure before the patient leaves the dental chair. | — |
Countries
India
Contacts
Public ContactDr Balasubramanian Madhan
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry
Outcome results
None listed