Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section

Fayoum University Hospital

Status: Completed

Conditions: Post-Dural Puncture Headache

Treatments: Drug: Sumatriptan 25 mg; Drug: Precedex

Study type: Interventional

Funder types: Other

Identifiers

NCT06514040

M684

Details and patient eligibility

About

comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section

Full description

A total of 48 patients will be randomly chosen to receive either inhaled dexmedetomidine (Group D, n= 24) or oral sumatriptan (Group S, n= 24) by a random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened once the patient is recruited and participants will receive either inhaled dexmedetomidine or oral sumatriptan as per the envelope. Data collectors will be blinded to the type of used medication (Dexmedetomidine or Sumatriptan).

Enrollment: 48 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pregnant female aged between 18 and 40 years old.
2. ASA II and III undergoing elective caesarean section.
3. Diagnosed with Postdural puncture headache with visual analogue score (VAS) ≥ 4 and Lybecker classification score ≥ 2.

Exclusion criteria

1. Patient refusal.
2. History of primary headaches such as migraine, cluster and tension headaches.
3. Hypersensitivity of dexmedetomidine or sumatriptan.
4. Hypertensive disorders of the pregnancy.
5. Contraindication to spinal anesthesia as coagulopathy or infection at site of injection.
6. Symptoms of ischemic heart disease (IHD) e.g. angina.
7. Cerebrovascular disease e.g. stroke or transient ischemic attacks (TIAs).
8. Using of Monoamine oxidase inhibitors (MAOIs) in the last 24h.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Precedex group

Active Comparator group

Description:

1- Inhaled Dexmedetomidine group (Group D, n= 24): will receive nebulization of 1 µg/kg dexmedetomidine (Precedex, Dexmedetomidine HCl 100 µg/mL, Pfizer Inc.) diluted in 4 mL 0.9% saline twice daily starting from the PDPH diagnosis time. The intervention will be continued until achieving a VAS score ≤ 3 and Lybecker classification score \< 2 or for a maximum of 48 hours when occurrence of side effects in form of hypotension, bradycardia, nausea stop the medication and give supportive treatment.

Treatment:

Drug: Precedex

Sumatriptan group

Active Comparator group

Description:

2- Oral sumatriptan group (Group S, n= 24): sumatriptan 25 mg every 8 hours orally when occurrence of side effects in form of paresthesia, dizziness and chest tightness stop the medication.

Treatment:

Drug: Sumatriptan 25 mg