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

NCT03997006 — Phase 4, Completed, 60 participants, Damanhour Teaching Hospital

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

Registry	NCT03997006, acronym RCT
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	60 (Actual)
Sponsor	Damanhour Teaching Hospital (Other gov)
Conditions	Post-Dural Puncture Headache
Interventions	IV Aminophylline, IV Neostigmine Methylsulfate + Atropine Sulphate (Drug)
Dates	start 2019-01-01, primary completion 2020-01-01, completion 2020-01-01, first posted 2019-06-25, last updated 2020-02-05
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group A (n=30)	Active comparator	Drug: IV Aminophylline	Aminophylline group
Group NA (n=30)	Active comparator	Drug: IV Neostigmine Methylsulfate + Atropine Sulphate	Neostigmine/Atropine group

IV Aminophylline (Drug), also known as Minophylline-N ampoule: IV Aminophylline (100 mg/8h)
IV Neostigmine Methylsulfate + Atropine Sulphate (Drug), also known as Neostigmine ampoule, Atropine ampoule: IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 21 Years to 50 Years

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

+Locations (1)

Facility	City	Country	Status
Damanhour Teaching Hospital	Damanhūr, El-Beheira	Egypt

+Investigators

Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital

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