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

Phase 4

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: IV Aminophylline; Drug: IV Neostigmine Methylsulfate + Atropine Sulphate

• Registration Number: NCT03997006
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (n=30)	IV Aminophylline	Aminophylline group
Group NA (n=30)	IV Neostigmine Methylsulfate + Atropine Sulphate	Neostigmine/Atropine group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt