<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20251121068066N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-27</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of intravenous caffeine, dexamethasone and aminophylline injection on headache after spinal anesthesia in patients undergoing section surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of intravenous caffeine, dexamethasone and aminophylline injection on headache after spinal anesthesia in patients undergoing section surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87900</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization was performed using block randomization to ensure balanced allocation across the four study groups. After obtaining written informed consent at the entrance to the operating room, eligible patients were randomly assigned to one of the four groups (control/placebo, caffeine, dexamethasone, or aminophylline). Fixed blocks of four were used, with each group appearing once in each block. The allocation order within each block was determined using a random number table, and this process continued until equal group sizes (35 participants per group) were achieved.</study_design>
      <phase>2</phase>
      <hc_freetext>Headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Caffeine Group: Participants receive intravenous caffeine at a dose of 500 mg diluted in 500 mL normal saline, administered immediately after delivery and placental separation. A second dose is administered 12 hours later. Patients are monitored for potential adverse effects, including tachycardia and cardiac arrhythmias. Intervention 2: Intervention group: Dexamethasone Group: Participants receive a single intravenous dose of 8 mg dexamethasone immediately after delivery and placental separation. Intervention 3: Intervention group: Aminophylline Group:Participants receive intravenous aminophylline at a dose of 0.4 mg/kg/hour, initiated immediately after delivery and placental separation. Intervention 4: Control group: Participants receive a placebo consisting of distilled water administered intravenously immediately after delivery of the newborn and placental separation.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akvan Paymard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Beheshti Hospital, Shahid Mohammad Montazeri Street</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 917 320 1908</telephone>
        <email>Akvan_paimard9@yahoo.com</email>
        <affiliation>Shahid Beheshti Hospital, Yasuj</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akvan Paymard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Beheshti Hospital, Shahid Mohammad Montazeri Street</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 917 320 1908</telephone>
        <email>Akvan_paimard9@yahoo.com</email>
        <affiliation>Shahid Beheshti Hospital, Yasuj</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No prior history of spinal anesthesia or post-dural puncture headache (PDPH).
Spinal anesthesia performed by an anesthesiologist using the same needle size and with only one puncture attempt.
No history of migraine headaches.
No contraindications to the study medications (caffeine, dexamethasone, or aminophylline).
Patients undergoing cesarean section with spinal anesthesia at Imam Sajjad Hospital in Yasuj.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Known allergy or contraindication to any of the study medications.
Use of additional oral or injectable analgesics during the study period.
Presence of headache prior to the surgery.
Withdrawal from participation or unwillingness to continue cooperation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug-induced headache, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Caffeine Group: Participants receive intravenous caffeine at a dose of 500 mg diluted in 500 mL normal saline, administered immediately after delivery and placental separation. A second dose is administered 12 hours later. Patients are monitored for potential adverse effects, including tachycardia and cardiac arrhythmias.</i_keyword>
      <i_keyword>Intervention group: Dexamethasone Group: Participants receive a single intravenous dose of 8 mg dexamethasone immediately after delivery and placental separation.</i_keyword>
      <i_keyword>Intervention group: Aminophylline Group:Participants receive intravenous aminophylline at a dose of 0.4 mg/kg/hour, initiated immediately after delivery and placental separation.</i_keyword>
      <i_keyword>Control group: Participants receive a placebo consisting of distilled water administered intravenously immediately after delivery of the newborn and placental separation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-spinal anesthesia headache severity measured using the 0–10 cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst pain. Pain intensity is categorized as mild (1–3), moderate (4–7), or severe (8–10). Timepoint: 24 hours after surgery. Method of measurement: Measurement method: Headache intensity is assessed using a 10-cm Visual Analogue Scale (VAS), where the patient marks their pain level. Scores are recorded by the researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-17</approval_date>
        <contact_name>Research Ethics Committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences Headquarters,Shahid Motahari Blvd, Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
