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

NCT05565274 | Unknown DMC

• 1 other identifier: FMCY/O&G/OCTAPPENALA/2022
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labor Pain

Keywords

Tramadol; Paracetamol; Pentazocine; Labour; Analgesia; Efficacy; Safety

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Participants with Good Service Satisfaction

  First 5 hours Post Delivery

• Analgesia Administration to Delivery interval

  First 2 hours Post Delivery

• Apgar Scores of the Neonates

  At first and fifth minutes after birth

• Special Care Baby Unit Admissions

  First 2 hours Post Delivery

Study Arms (2)

Tramadol plus Paracetamol

EXPERIMENTAL

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

Drug: Pentazocine plus placebo

Pentazocine plus placebo

ACTIVE COMPARATOR

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

Drug: Pentazocine plus placebo

Interventions

Pentazocine plus placebo DRUG

30mg of pentazocine and 2milliLitre of injection water

Pentazocine plus placebo; Tramadol plus Paracetamol

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Medical Centre, Yenagoa: lead

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Pentazocine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzomorphans; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Andrew Orhorho

  Federal Medical Center, Yenagoa Bayelsa State Southern Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Orhorho, MBBS

CONTACT

+2348068616620; andypee2016@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: "Randomized"

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available by December 2023