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出境医 / 临床实验 / Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache (RCT)
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache (RCT)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-Dural Puncture Headache | Drug: IV Aminophylline Drug: IV Neostigmine Methylsulfate + Atropine Sulphate | Phase 4 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial |
| Actual Study Start Date : | January 1, 2019 |
| Actual Primary Completion Date : | January 1, 2020 |
| Actual Study Completion Date : | January 1, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Group A (n=30)
Aminophylline group
|
Drug: IV Aminophylline
IV Aminophylline (100 mg/8h)
Other Name: Minophylline-N ampoule
|
|
Active Comparator: Group NA (n=30)
Neostigmine/Atropine group
|
Drug: IV Neostigmine Methylsulfate + Atropine Sulphate
IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
Other Name: Neostigmine ampoule, Atropine ampoule
|
Outcome Measures
Primary Outcome Measures :
- Median and Range of Numeric Pain Rating Scale (NPRS) score [ Time Frame: 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 :
- Mean and Standard deviation of PDPH duration (hours) (mean±SD) [ Time Frame: 48 hours after initiation of treatment ]Time from PDPH onset till NPRS score ≤ 3
- Number of participants and Rate of Treatment-related complications [ Time Frame: 48 hours after initiation of treatment ]Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity
Eligibility Criteria
| Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
| Egypt | |
| Damanhour Teaching Hospital | |
| Damanhūr, El-Beheira, Egypt | |
Sponsors and Collaborators
Damanhour Teaching Hospital
Investigators
| Principal Investigator: | Ahmed M Shaat, MD | Damanhour Teaching Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 20, 2019 | ||||
| First Posted Date ICMJE | June 25, 2019 | ||||
| Last Update Posted Date | February 5, 2020 | ||||
| Actual Study Start Date ICMJE | January 1, 2019 | ||||
| Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Median and Range of Numeric Pain Rating Scale (NPRS) score [ Time Frame: 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)
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| Original Primary Outcome Measures ICMJE |
Median and Range of Numeric Pain Rating Scale (NPRS) score [ Time Frame: 72 hours after initiation of treatment ] NPRS measures the severity of PDPH (before, 2h, 6h, then every 6h till 72h)
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache | ||||
| Official Title ICMJE | Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Post-Dural Puncture Headache | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
60 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | January 1, 2020 | ||||
| Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years to 50 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03997006 | ||||
| Other Study ID Numbers ICMJE | DTH:19001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Damanhour Teaching Hospital | ||||
| Study Sponsor ICMJE | Damanhour Teaching Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Damanhour Teaching Hospital | ||||
| Verification Date | February 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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