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

Damanhour Teaching Hospital

Status and phase: Completed; Phase 4

Conditions: Post-Dural Puncture Headache

Treatments: Drug: IV Aminophylline; Drug: IV Neostigmine Methylsulfate + Atropine Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03997006

DTH:19001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group A (n=30)

Active Comparator group

Description:

Aminophylline group

Treatment:

Drug: IV Aminophylline

Group NA (n=30)

Active Comparator group

Description:

Neostigmine/Atropine group

Treatment:

Drug: IV Neostigmine Methylsulfate + Atropine Sulphate