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
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
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
NCT ID
NCT05565274
First Posted
September 26, 2022
Last Updated
September 30, 2022
Sponsor
Federal Medical Centre, Yenagoa
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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