An interventional study of Intravenous ondansetron and Intravenous normal saline in Post-Dural Puncture Headache, sponsored by Mongi Slim Hospital. Recruiting at 1 site in Tunisia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Mongi Slim Hospital · Not applicable, Interventional, and Prevention
A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:
Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.
Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.
the investigators included in the study all parturients:
The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.
were assigned to one of the two parallel groups to receive either :
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 79 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Mongi Slim Hospital is the lead sponsor of 38 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
As well as patients who have subsequently withdrawn their consent for participating to our study.
Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Drug: Intravenous ondansetron
Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
Drug: Intravenous normal saline
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Also known as: ondansetron
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Also known as: Placebo
Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
the occurrence of positional headaches at any time postoperatively
Time frame: 7 days
day of PDPH's occurence
on postoperatively
Time frame: 7 days
day of PDPH's resolution
on postoperatively
Time frame: 7 days
Headache severity
assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).
Time frame: 7 days
Need for analgesic treatment due to headaches
paracetamol or NSAIDs
Time frame: 7 days
Occurrence of post-operative nausea and/or vomiting
need of treatement
Time frame: 7 days
Mean arterial pressure in mmgh
Mean arterial pressure during hospitalization
Time frame: 3 days
heart rate
Mean arterial pressure during hospitalization
Time frame: 3 days
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Studies of the drug tested here: Ondansetron
Post-Dural Puncture Headache →
Mongi Slim Hospital