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

Headache Clinical Trial

Official title:

Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache: a Randomized Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760862
• Other study ID #: 1102
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• hydrocortisone 100mg.
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours
• mannitol 20% intravenous fluid
group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.		within 48 hours after starting of treatment