Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Headache

Treatments: Drug: hydrocortisone 100mg.; Drug: mannitol 20% intravenous fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT02760862

1102

Details and patient eligibility

About

Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 18-50 years old.
• both sex.
• ASA physical status I and II.
• 70-90 kg body weight.
• height 160-180 cm.
• Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.

Exclusion criteria

• Patients with impaired kidney or liver functions.
• history of cardiac or central nervous system disease.
• uncontrolled medical disease (diabetes mellitus and hypertension)
• history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
• allergy to the used medications
• patient's refusal
• duration of surgery more than 120 minutes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group (I) (N=25)

Active Comparator group

Description:

Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).

Treatment:

Drug: hydrocortisone 100mg.

Group (II) (N=25)

Active Comparator group

Description:

group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).

Treatment:

Drug: mannitol 20% intravenous fluid