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It is hypothesized that there is a difference between intravenously administered aminophylline with intravenous acetaminophen and intravenously administered aminophylline with dexamethasone for prevention of and reducing severity of PDPH.
Aim of the study is to compare intravenous aminophylline plus dexamethasone with intravenous acetaminophen and intravenous aminophylline on post dural puncture headache prevention after spinal anesthesia in terms of incidence of PDPH, VAS scores between the groups. . Patients will be randomly divided into two equal groups. (Group A1) who will receive aminophylline with acetaminophen infusion slowly and (Group A2) who will receive aminophylline with dexamethasone Infusion. Study variables will be noted in predesigned study proforma. Data will be entered on software SPSS version 26.0 and will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen+Aminophylline (n=25) | Experimental | This group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. |
|
| Aminophylline+Dexamethasone (n=25) | Experimental | This group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline | Drug | This group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH. | Reduced Incidence of PDPH | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone on post-dural puncture headache prevention after spinal anesthesia in terms of reduced severity of PDPH by VAS scores. | ● Reduced serverity of PDPH by VAS scores by prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone in patients with previous history of PDPH. |
| Measure | Description | Time Frame |
|---|---|---|
| *Reduced need for Rescue analgesia and *Reduced associated symptoms of PDPH after prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone. | The combination of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone reduce the need for rescue analgesia. Moreover, the combination of drugs reduce the associated symptoms of PDPH like diplopia, nausea, vomiting and neck stiffness. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Faisal Masood Teaching Hospital, Sargodha | Sargodha | Punjab Province | 40100 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Jabalameli, M., Hashemi, S.T., Asadpoor, S., 2019. The efficacy of prophylactic intravenous aminophylline, paracetamol or aminophylline and paracetamol in prevention of post spinal headache in lower extremity surgeries compared to the control group. Tehran Univ. Medical J., 77(5), pp.294-300. |
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After approval of synopsis and approval from Institutional Ethical Review Board (IERB), 50 patients undergoing elective lower abdominopelvic and lower limb surgeries as per inclusion criteria in this study will be enrolled in this study.Two equal groups will be constituted. Informed consent will be taken from all patients after explaining the whole procedure, its merits, demerits, and alternate treatment options. Group A1 (n=25) will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion. Group A2 (n=25) will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.Drugs will be given in infusion form at the end of the procedure and once daily for 3 days. Coded Drug infusions will be administered by an anesthetist blinded to study groups at the end of the procedure in operation theatre and once daily
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|
| Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline | Drug | This group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion. |
|
|
| 3 days |
| 3 days |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000628 | Aminophylline |
| D000082 | Acetaminophen |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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