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

A

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems