Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache

Post-Dural Puncture Headache Clinical Trial

— RCT  

Official title:

Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997006
• Other study ID #: DTH:19001
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2020
• Source: Damanhour Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).

Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.

Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with NPRS score of = 5

• American Society of Anesthesiologists (ASA) physical status = II

• Age from 21 to 50 years

Exclusion Criteria:

• Patients with NPRS score < 5

• ASA physical status > II

• Age < 21 years or > 50 years

• Pregnant women

• History of; chronic headache, Cluster headache, Migraine

• History of; Convulsions, Cerebrovascular accident, Previous neurological diseases

• Signs of meningismus

• Bronchial asthma

• Arrhythmia

• Hypertension

• Ischemic heart disease

• Hyperthyroidism

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Wounds and Injuries

Intervention

Drug:
• IV Aminophylline
IV Aminophylline (100 mg/8h)
• IV Neostigmine Methylsulfate + Atropine Sulphate
IV Neostigmine/Atropine mixture (20 µg/kg Neostigmine + 10 µg/kg Atropine)/8h

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median and Range of Numeric Pain Rating Scale (NPRS) score	NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, then every 12h till 48h)	48 hours after initiation of treatment
Secondary	Mean and Standard deviation of PDPH duration (hours) (mean±SD)	Time from PDPH onset till NPRS score = 3	48 hours after initiation of treatment
Secondary	Number of participants and Rate of Treatment-related complications	Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity	48 hours after initiation of treatment