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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03997006

Acronym

RCT

Enrollment

Registered

2019-06-25

Start date

2019-01-01

Completion date

2020-01-01

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

Keywords

Aminophylline, Atropine, Neostigmine, Post-dural puncture headache, Spinal anesthesia

Brief 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.

Interventions

DRUGIV Aminophylline

IV Aminophylline (100 mg/8h)

DRUGIV Neostigmine Methylsulfate + Atropine Sulphate

IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Median and Range of Numeric Pain Rating Scale (NPRS) score	48 hours after initiation of treatment	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)

Secondary

Measure	Time frame	Description
Mean and Standard deviation of PDPH duration (hours) (mean±SD)	48 hours after initiation of treatment	Time from PDPH onset till NPRS score ≤ 3
Number of participants and Rate of Treatment-related complications	48 hours after initiation of treatment	Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026