This study aimed to assess how effective nebulized dexmedetomidine is at lowering headache intensity and enhancing satisfaction levels in individuals suffering from post-dural puncture headache.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Both Patient and Caregiver are blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria
All Patients aged between 18 and 40 years, who developed PDPH after spinal anesthesia were included in study
Exclusion Criteria
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.
Intervention groups
Nebulisation with Dexmeditomidine VS Nebulization with Normal Saline
Main outcome variables
Post Dural Puncture Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260831070845N1
Registration date:2026-09-07, 1405/06/16
Registration timing:retrospective
Last update:2026-09-07, 1405/06/16
Update count:0
Registration date
2026-09-07, 1405/06/16
Registrant information
Name
Ahsan Ali
Name of organization / entity
Pak Emirates Military Hospital
Country
Pakistan
Phone
+92 300 1750592
Email address
drahsan105467@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-01, 1404/09/10
Expected recruitment end date
2026-05-30, 1405/03/09
Actual recruitment start date
2025-12-01, 1404/09/10
Actual recruitment end date
2026-05-30, 1405/03/09
Trial completion date
2026-05-30, 1405/03/09
Scientific title
Nebulized Dexmedetomidine as a Therapeutic Approach for Post-Dural Puncture Headache Following Spinal Anesthesia in Elective Caesarean Delivery
Public title
Dexmedetomidine for Post-dural Puncture Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients aged between 18 and 40 years, who developed PDPH after spinal anesthesia were included in study
Exclusion criteria:
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.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of CMH Attock
Street address
Combined Military Hospital Attock
City
Attock
Postal code
43600
Approval date
2025-01-10, 1403/10/21
Ethics committee reference number
CMH ATK/EC/01/2025
Health conditions studied
1
Description of health condition studied
Post-dural puncture Headache
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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.
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Ahsan Ali
Street address
Flat F-1, Parade Lane Rawalpindi
City
Attock
Postal code
46000
Phone
+92 300 1750592
Fax
Email
drahsan105467@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Combined Military Hospital Attock
Full name of responsible person
Lt Col DR Raja Nand
Street address
CMH ATTOCK
City
Attock
Postal code
46000
Phone
+92 300 1750592
Fax
Email
drahsan105467@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Lt Col DR Raja Nand
Street address
CMH ATTOCK
City
Attock
Postal code
46000
Phone
+92 333 2743315
Fax
Email
drrajanand1984@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Ahsan Ali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Flat F-1, Parade Lane Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 300 1750592
Fax
Email
drahsan105467@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Ahsan Ali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Flat F-1, Parade Lane Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 300 1750592
Fax
Email
drahsan105467@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Ahsan Ali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Flat F-1, Parade Lane Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 300 1750592
Fax
Email
drahsan105467@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD