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IRCT20260831070845N1 IRCT 2026-09-07 Combined Military Hospital Rawalpindi Dexmedetomidine for Post-dural Puncture Headache Nebulized Dexmedetomidine as a Therapeutic Approach for Post-Dural Puncture Headache Following Spinal Anesthesia in Elective Caesarean Delivery 2025-12-01 anticipated 60 Complete https://irct.ir/trial/92909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: The study employed a simple randomization method using a lottery format, focused on individual patients as the unit of randomization. Allocation was carefully concealed to enhance the integrity of the trial, and while stratification was not explicitly noted, it could have been considered for certain baseline variables. The combination of these techniques strengthens the validity of the findings in assessing the efficacy of nebulized dexmedetomidine for post-dural puncture headache management, Blinding description: Our study implemented a comprehensive blinding strategy across all involved parties—from participants to manuscript writers—to safeguard against biases that could compromise the validity of the findings. This thorough approach enhances the reliability of the study results in evaluating the effectiveness of nebulized dexmedetomidine for treating post-dural puncture headaches. N/A Post-dural puncture Headache. Intervention 1: Intervention Group:Details: Participants received nebulized dexmedetomidine at a concentration of 0.5 mg/mL.Method: Administered via a nebulizer.Duration: 10 minutes.Frequency: Once, immediately after the diagnosis of post-dural puncture headache. Intervention 2: Control Group:Details: Participants received a placebo treatment consisting of nebulized saline solution (0.9% sodium chloride).Method: Administered using the same method as the intervention group.Duration: 10 minutes.Frequency: Once, immediately after the diagnosis of post-dural puncture headache. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further Info please

public Ahsan Ali

Flat F-1, Parade Lane Rawalpindi

Rawalpindi Pakistan 46000 +92 300 1750592 drahsan105467@gmail.com Pak Emirates Military Hospital scientific Ahsan Ali

Flat F-1, Parade Lane Rawalpindi

Rawalpindi Pakistan 46000 +92 300 1750592 drahsan105467@gmail.com Pak Emirates Military Hospital Pakistan Pakistan All Patients aged between 18 and 40 years, who developed PDPH after spinal anesthesia were included in study 18 years 40 years Female Patients with pre-existing chronic headache or migraine disorder, Cardiac Abnormalities including Atrio-Ventricular blocks and Bundle Branch Blocks, uncontrolled hypertension or neurological disease, hypersensitivity to dexmedetomidine, respiratory illness preventing nebulization therapy, Patients refusing consent or Patients requiring immediate epidural blood patch were excluded from study. Treatment - Drugs Treatment - Other Intervention Group:Details: Participants received nebulized dexmedetomidine at a concentration of 0.5 mg/mL.Method: Administered via a nebulizer.Duration: 10 minutes.Frequency: Once, immediately after the diagnosis of post-dural puncture headache. Control Group:Details: Participants received a placebo treatment consisting of nebulized saline solution (0.9% sodium chloride).Method: Administered using the same method as the intervention group.Duration: 10 minutes.Frequency: Once, immediately after the diagnosis of post-dural puncture headache. Patient Satisfaction score. Timepoint: After 24 Hours, After 48 Hours and 72 Hours. Method of measurement: The VAS is widely recognized for its reliability and sensitivity in measuring pain intensity, making it a suitable choice for assessing the primary outcome of headache relief in this study. Time to Onset of Pain Relief: Measurement: Recorded time (in minutes) from treatment administration to the first report of pain relief by the participant. Overall Satisfaction with Treatment: Measurement: Assessed using a satisfaction scale or questionnaire post-treatment, where participants rate their experience. Adverse Effects: Measurement: Monitoring the incidence of side effects or adverse reactions reported by participants post-treatment. Timepoint: Time Intervals for Measuring Secondary OutcomesTime to Onset of Pain Relief: Measurement Points: Immediately post-intervention (0 minutes)15 minutes after intervention30 minutes after intervention Overall Satisfaction with Treatment: Measurement Points:Immediately post-treatment24 hours after intervention Adverse Effects:Measurement Points:Immediately post-treatment24 hours after intervention48 hours after intervention. Method of measurement: Time to Onset of Pain Relief:Measurement Tool: Self-reported time by participants.Method: Participants will record the time (in minutes) from the end of the nebulization treatment until they first experience noticeable pain relief, if any. Overall Satisfaction with Treatment:Measurement Tool: Satisfaction questionnaire (e.g., a Likert scale).Method: Participants will be asked to rate their satisfaction with the treatment on a scale from 1 to 5 (1 = very dissatisfied, 5 = very satisfied) immediately post-treatment and again 24 hours later .Adverse Effects:Measurement Tool: Adverse event reporting form.Method: Participants will be asked to report any side effects or symptoms they experience immediately post-treatment, as well as 24 and 48 hours afterward. Investigators will also monitor for any serious adverse events throughout the study period. Combined Military Hospital Rawalpindi Approved 2025-01-10 Ethics Committee of CMH Attock Combined Military Hospital Attock Attock Punjab Pakistan