Phase 4
N=50
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
Headache
Bottom Line
View on ClinicalTrials.gov: NCT02760862 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol. — 25; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- hydrocortisone 100mg. (Drug); mannitol 20% intravenous fluid (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ain Shams University
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol. |
25; 25 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02760862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.