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

Labor Pain Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565274
• Other study ID #: FMCY/O&G/OCTAPPENALA/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: February 2023

Study information

• Verified date: September 2022
• Source: Federal Medical Centre, Yenagoa
• Contact: Andrew Orhorho, MBBS
• Phone: +2348068616620
• Email: andypee2016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 166
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Pentazocine plus placebo
30mg of pentazocine and 2milliLitre of injection water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal Medical Centre, Yenagoa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 hour post analgesia administration
Primary	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)	2 hours post analgesia administration
Primary	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)	3 hours post analgesia administration
Primary	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)	4 hours post analgesia administration
Primary	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)	5 hours post analgesia administration
Primary	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	Time of first analgesia administration to 2 hours Post Delivery
Secondary	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.	First 5 hours Post Delivery
Secondary	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.	First 2 hours Post Delivery
Secondary	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	At first and fifth minutes after birth
Secondary	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.	First 2 hours Post Delivery