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

• To assess the incidence and severity of postoperative sore throat (POST) in patients receiving preoperative nebulized dexamethasone and intravenous ketorolac. • To compare the anti-inflammatory effect of Steroid (Dexamethasone) versus non-steroid (Ketorolac tromethamine) in reducing POST.

This study employed a randomized, double-blinded research design.

The study was be conducted at Farooq Hospital, DHA, specifically within the Department of Anesthesia.

Inclusion criteria: • Patients aged 18 – 50 undergoing surgeries that require endotracheal intubation after general anesthesia • ASA Physical status of I–III. • Patient giving informed consent. Exclusion criteria. • 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

Interventions: Group K (Ketorolac group): Participants in this group will receive intravenous ketorolac tromethamine preoperatively, 15–30 minutes before induction of general anesthesia. Group D (Dexamethasone group): Participants in this group will receive nebulized dexamethasone preoperatively, 15–30 minutes before induction of general anesthesia.

Main Outcome Variables: Incidence of Postoperative Sore Throat (POST): Presence or absence of sore throat at 2, 4, 6, and 12 hours after extubation. Severity of Postoperative Sore Throat: Measured using the STAT-10 scale at 2, 4, 6, and 12 hours post-extubation. Anti-inflammatory Effect of Intervention: Assessed indirectly through reduction in sore throat severity scores between the two groups.

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.

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.

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