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IRCT20260222068917N1 IRCT 2026-02-25 Superior University, Lahore A Randomized, Double-Blinded Comparative Study of Pre-Operative Nebulized Dexamethasone and Intravenous Ketorolac Tromethamine for the Prevention of Post-Operative Sore Throat Following General Anesthesia POST: Postoperative Sore Throat A Randomized, Double-Blinded Comparative Study of Pre-Operative Nebulized Dexamethasone and Intravenous Ketorolac Tromethamine for the Prevention of Post-Operative Sore Throat Following General Anesthesia 2025-07-16 anticipated 100 Complete https://irct.ir/trial/89232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in this study were allocated to either the pre-operative nebulized dexamethasone group or the intravenous ketorolac tromethamine group using simple randomization at the level of the individual participant. No stratified randomization was applied, as the study population was homogeneous regarding age, gender, and type of surgery. The random sequence was prepared manually using a table of random numbers, and each participant was assigned a unique sequential number upon enrollment, which was then matched to the pre-prepared random allocation list to determine group assignment. Allocation concealment was maintained using sealed opaque envelopes, which were opened only at the time of intervention to prevent selection bias. No pseudorandomization methods, such as odd/even days, birthdays, or physician choice, were used, Blinding description: In this study, participants are blinded to the type of intervention they receive, as both nebulized dexamethasone and intravenous ketorolac tromethamine are administered in a manner that conceals group allocation. The principal investigator and outcome assessors are also blinded to group assignments to prevent assessment bias when recording postoperative sore throat outcomes. Healthcare providers administering the interventions are aware of the treatment for practical reasons but do not participate in outcome assessment. Data collectors and individuals entering and analyzing the data are blinded to group allocation to maintain objectivity. A sealed opaque envelope system ensures that group allocation remains concealed until the intervention is given. The Data Safety and Monitoring Board (DSMB) and manuscript writers are not involved in treatment administration or outcome assessment and remain unaware of group assignments until study completion. This blinding strategy minimizes bias at multiple levels of the study while maintaining safety and practical feasibility. N/A Postoperative Sore Throat (POST) following General Anesthesia. Intervention 1: Intervention Group 1: Group D – Dexamethasone, Participants receive preoperative nebulized dexamethasone, 15–30 minutes before induction of general anesthesia. Intervention 2: Intervention group 2: Group K – Ketorolac, Participants receive intravenous ketorolac tromethamine, 15–30 minutes before induction of general anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Abdul Mabood
17 Km Raiwind Road, Lahore, Pakistan
Lahore Pakistan 54000 +92 345 8561831 abdulmabood856@gmail.com Superior University, Lahore scientific Abdul Mabood
17 Km Raiwind Road, Lahore, Pakistan
Lahore Pakistan 54000 +92 345 8561831 abdulmabood856@gmail.com Superior University, Lahore Pakistan Patients aged 18 – 50 undergoing surgeries that require endotracheal intubation after general anesthesia ASA Physical status of I–III Patient giving informed consent. 18 years 50 years Both Patient known to be allergic to study drugs Asthmatic or COPD patients ASA physical status IV – VI The Patient has a pre-existing sore throat or pain Surgeries involving the neck, throat, or airway Upper respiratory tract infection Patients with a history of renal disease Treatment - Drugs Treatment - Drugs Intervention Group 1: Group D – Dexamethasone, Participants receive preoperative nebulized dexamethasone, 15–30 minutes before induction of general anesthesia. Intervention group 2: Group K – Ketorolac, Participants receive intravenous ketorolac tromethamine, 15–30 minutes before induction of general anesthesia. Incidence and Severity of Postoperative Sore Throat (POST). Timepoint: Measured at 2, 4, 6, and 12 hours after extubation. Method of measurement: Severity was assessed using the STAT-10 scale, a validated questionnaire for postoperative sore throat.Incidence is recorded as the presence or absence of sore throat at each time point. . Timepoint: . Method of measurement: . Secondary outcomes include intubation-related factors (number of attempts and their association with POST severity), cuff pressure categories (≤24 vs >24 cm H₂O), surgery-related factors (type and duration of surgery), endotracheal tube size, postoperative complications (nausea, vomiting, GI irritation, hyperglycemia, delayed wound healing, and others), and requirement for rescue analgesia. Timepoint: Secondary outcomes was measured at 2, 4, 6, and 12 hours after extubation for outcomes related to POST and complications. Method of measurement: The secondary outcomes are measured using a combination of direct observation, structured questionnaires, and patient records. Intubation attempts and endotracheal tube size are recorded intraoperatively from anesthesia notes. Cuff pressure is measured using a manometer at the time of intubation. Surgery type and duration are documented from operative records. Postoperative complications such as nausea, vomiting, GI irritation, hyperglycemia, delayed wound healing, and others are monitored through direct observation and patient self-report. Rescue analgesia requirement is recorded from patient charts and by direct inquiry during the 12-hour postoperative period. Outcome assessors are blinded to group allocation to minimize bias. Superior University, Lahore Approved 2025-10-16 The Research Ethical Committee, Superior University, Lahore 17 Km Raiwind Road, Lahore, Pakistan Lahore Punjab Pakistan