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Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients (OCTAPPENALA)

Primary Purpose

Labor Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pentazocine plus placebo
Sponsored by
Federal Medical Centre, Yenagoa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Tramadol, Paracetamol, Pentazocine, Labour, Analgesia, Efficacy, Safety

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All pregnant women who presented in spontaneous labour at term, carrying Singleton Live Fetus in Active Phase of Labour with Cervical dilatation of 4-6cm who gave consent to participate in the study

Exclusion Criteria:

  • Women with severe medical conditions such as diabetes mellitus, severe pre-eclampsia, cardiac, liver and renal disease
  • Preterm Labour
  • Intrauterine Fetal Death
  • Fetal presentation other than cephalic
  • Patients with previous caeserean section
  • History of hypersensitivity to paracetamol, tramadol and pentazocine
  • Complications such as antepartum haemarrhage, polyhydramnious, premature rupture of membrane
  • Use of any kind of analgesia before recruitment
  • Multiple gestation
  • All other delivery except spontaneous vertex delivery Labour that was induced or augmented

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tramadol plus Paracetamol

    Pentazocine plus placebo

    Arm Description

    2ml of 100mg of intramuscular tramadol plus 2ml of 600mg of intramuscular paracetamol unlabeled

    2ml of 30mg of pentazocine plus 2 ml of water for injection will be administered intramuscularly during labour

    Outcomes

    Primary Outcome Measures

    To Evaluate the Number of Participants with Pain After 1 hour of Analgesia Administration
    Pain was Assessed during Labour 1 hour Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    To Evaluate the Number of Participants with Pain After 2 hours of Analgesia Administration
    Pain was Assessed during Labour 2 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    To Evaluate the Number of Participants with Pain After 3 hours of Analgesia Administration
    Pain was Assessed during Labour 3 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    To Evaluate the Number of Participants with Pain 4 hours After Analgesia Administration
    Pain was Assessed during Labour 4 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    To Evaluate the Number of Participants with Pain 5 hours After Analgesia Administration
    Pain was Assessed during Labour 5 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    Number of Participants with Treatment Related Adverse Events on both arms
    Number of Participants with Treatment Related Adverse Events such as Nausea, Vomiting, Hypersensitivity Reaction, respiratory depression and any other Adverse Effects from the time of first administation to 2 hours post delivery

    Secondary Outcome Measures

    Participants with Good Service Satisfaction
    Good Service Satisfaction among participants was Assessed on both arms of the study using the 5-Point Likert's Scale administered in the first 5 hours of delivery. The 5-Point Likert's Scale contains 5 response Options that consist of two extreme sides and a neutral option at the middle. The 5 responses are; very dissatisfied, Dissatisfied, Neither Dissatisfied or Satisfied, Satisfied and Very Satisfied. Participants responsibility is to choose from any of these responses in the administered questionnaire.
    Analgesia Administration to Delivery interval
    To compare the interval between analgesia administration and the time it took participants to deliver on both arms of the study. This was recorded within the first 2 hours of delivery.
    Apgar Scores of the Neonates
    To Evaluate the well being of Neonates delivered on both arms of the study using the Apgar Scores taken at the first and fifth minutes. Apgar Score has a minimum of 0, a maximum score of 10 and a range of 0-10, where higher score mean a better outcome (0-3= low Apgar Score, 4-6= Moderately Abnormal Apgar Score and 7-10= Good Apgar Score
    Special Care Baby Unit Admissions
    To Evaluate the number of Neonates that were admitted into the Special Care Baby Unit within 2 hours of birth. The Special Care Baby Unit is an intensive care unit where optimal emergency treatment is given to the newborn with health related challenges to increase their chance of survival.

    Full Information

    First Posted
    September 26, 2022
    Last Updated
    September 30, 2022
    Sponsor
    Federal Medical Centre, Yenagoa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05565274
    Brief Title
    Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients
    Acronym
    OCTAPPENALA
    Official Title
    Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients in the Federal Medical Center, Yenagoa, Bayelsa State, Southern Nigeria: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal Medical Centre, Yenagoa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Labour is a very painful experience and epidural analgesia is considered the gold standard for pain relief in labour. Epidural scarcity, cost and shortage of skilled personnel to administer it is a limitation to it's usage in developing countries. Parenteral opioid analgesics such as pethidine and pentazocine are effective labour analgesia commonly used in developing countries but are limited by their side effects. This limitation in their use call for the need for alternative analgesic with similar or superior analgesic effect but with minimal side effects.The study is aimed at evaluating the efficacy and safety of combined tramadol and paracetamol in reducing labour pain among parturients.
    Detailed Description
    There is paucity of data in our environment looking at the efficacy and safety of combined tramadol and paracetamol in relieving labour pain. This study will offer us great opportunity to evaluate their synergistic effect in labour when compared to the commonly used single opioids such as pethidine or pentazocine. It would be a double blinded randomized controlled trial. One hundred and sixty-six pregnant eligible women in labour would participate in this study. Participants will be randomized equally into two study arms ( Tramadol plus Paracetamol study arm and Pentazocine study arm) after informed consent. The Tramadol plus Paracetamol study arm will receive 100mg of tramadol plus 600mg of paracetamol intramuscularly in a 2ml and 5ml syringe respectively while the pentazocine study arm will receive 30mg of Pentazocine and 2 milliliters of water for injection as placebo intramuscularly in a 2l and 5 ml syringes respectively. Both drugs will be administered to the participants at 4-6cm cervical dilatation during labour. The outcome measures will be evaluated within 5 hours in labour and an hour immediately after delivery. The need for additional rescue analgesia will be assessed as well. Fetal outcome on both arms will be noted too.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain
    Keywords
    Tramadol, Paracetamol, Pentazocine, Labour, Analgesia, Efficacy, Safety

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    "Randomized"
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The hospital Pharmacist will prepare the drugs in both arms where the first arm will be 2 ml of 100mg tramadol in 5 ml syringe and 2ml of 600mg Paracetamol in 5 ml syringe as well. The second arm will be 2ml of 30mg pentazocine in 5ml syringe plus 2ml of water for injection. Both arms of the medications will be pre-packed in opaque envelopes and labelled by the pharmacist as either A or B who will take no further part in the study. These will be assigned based on the randomized outcome. The randomization list will be on the possession of research assistant who will take no further part in the study after randomly assigning participants to the study arms till the end of the study.
    Allocation
    Randomized
    Enrollment
    166 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol plus Paracetamol
    Arm Type
    Experimental
    Arm Description
    2ml of 100mg of intramuscular tramadol plus 2ml of 600mg of intramuscular paracetamol unlabeled
    Arm Title
    Pentazocine plus placebo
    Arm Type
    Active Comparator
    Arm Description
    2ml of 30mg of pentazocine plus 2 ml of water for injection will be administered intramuscularly during labour
    Intervention Type
    Drug
    Intervention Name(s)
    Pentazocine plus placebo
    Intervention Description
    30mg of pentazocine and 2milliLitre of injection water
    Primary Outcome Measure Information:
    Title
    To Evaluate the Number of Participants with Pain After 1 hour of Analgesia Administration
    Description
    Pain was Assessed during Labour 1 hour Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    Time Frame
    1 hour post analgesia administration
    Title
    To Evaluate the Number of Participants with Pain After 2 hours of Analgesia Administration
    Description
    Pain was Assessed during Labour 2 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    Time Frame
    2 hours post analgesia administration
    Title
    To Evaluate the Number of Participants with Pain After 3 hours of Analgesia Administration
    Description
    Pain was Assessed during Labour 3 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    Time Frame
    3 hours post analgesia administration
    Title
    To Evaluate the Number of Participants with Pain 4 hours After Analgesia Administration
    Description
    Pain was Assessed during Labour 4 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    Time Frame
    4 hours post analgesia administration
    Title
    To Evaluate the Number of Participants with Pain 5 hours After Analgesia Administration
    Description
    Pain was Assessed during Labour 5 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
    Time Frame
    5 hours post analgesia administration
    Title
    Number of Participants with Treatment Related Adverse Events on both arms
    Description
    Number of Participants with Treatment Related Adverse Events such as Nausea, Vomiting, Hypersensitivity Reaction, respiratory depression and any other Adverse Effects from the time of first administation to 2 hours post delivery
    Time Frame
    Time of first analgesia administration to 2 hours Post Delivery
    Secondary Outcome Measure Information:
    Title
    Participants with Good Service Satisfaction
    Description
    Good Service Satisfaction among participants was Assessed on both arms of the study using the 5-Point Likert's Scale administered in the first 5 hours of delivery. The 5-Point Likert's Scale contains 5 response Options that consist of two extreme sides and a neutral option at the middle. The 5 responses are; very dissatisfied, Dissatisfied, Neither Dissatisfied or Satisfied, Satisfied and Very Satisfied. Participants responsibility is to choose from any of these responses in the administered questionnaire.
    Time Frame
    First 5 hours Post Delivery
    Title
    Analgesia Administration to Delivery interval
    Description
    To compare the interval between analgesia administration and the time it took participants to deliver on both arms of the study. This was recorded within the first 2 hours of delivery.
    Time Frame
    First 2 hours Post Delivery
    Title
    Apgar Scores of the Neonates
    Description
    To Evaluate the well being of Neonates delivered on both arms of the study using the Apgar Scores taken at the first and fifth minutes. Apgar Score has a minimum of 0, a maximum score of 10 and a range of 0-10, where higher score mean a better outcome (0-3= low Apgar Score, 4-6= Moderately Abnormal Apgar Score and 7-10= Good Apgar Score
    Time Frame
    At first and fifth minutes after birth
    Title
    Special Care Baby Unit Admissions
    Description
    To Evaluate the number of Neonates that were admitted into the Special Care Baby Unit within 2 hours of birth. The Special Care Baby Unit is an intensive care unit where optimal emergency treatment is given to the newborn with health related challenges to increase their chance of survival.
    Time Frame
    First 2 hours Post Delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    All pregnant women who presented in spontaneous labour at term, carrying Singleton Live Fetus in Active Phase of Labour with Cervical dilatation of 4-6cm who gave consent to participate in the study
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All pregnant women who presented in spontaneous labour at term, carrying Singleton Live Fetus in Active Phase of Labour with Cervical dilatation of 4-6cm who gave consent to participate in the study Exclusion Criteria: Women with severe medical conditions such as diabetes mellitus, severe pre-eclampsia, cardiac, liver and renal disease Preterm Labour Intrauterine Fetal Death Fetal presentation other than cephalic Patients with previous caeserean section History of hypersensitivity to paracetamol, tramadol and pentazocine Complications such as antepartum haemarrhage, polyhydramnious, premature rupture of membrane Use of any kind of analgesia before recruitment Multiple gestation All other delivery except spontaneous vertex delivery Labour that was induced or augmented
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Orhorho, MBBS
    Phone
    +2348068616620
    Email
    andypee2016@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Orhorho
    Organizational Affiliation
    Federal Medical Center, Yenagoa Bayelsa State Southern Nigeria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    The data will be available by December 2023

    Learn more about this trial

    Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients

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