Clinical trial NCT05565274: Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Keywords: Tramadol
Paracetamol
Pentazocine
Labour
Analgesia
Efficacy
Safety
Lead sponsor: Federal Medical Centre, Yenagoa
Sponsor class: OTHER_GOV
First posted: 2022-10-04
Enrollment: 166
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "Randomized"
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: To Evaluate the Number of Participants with Pain After 1 hour of Analgesia Administration
timeFrame: 1 hour post analgesia administration
measure: To Evaluate the Number of Participants with Pain After 2 hours of Analgesia Administration
timeFrame: 2 hours post analgesia administration
measure: To Evaluate the Number of Participants with Pain After 3 hours of Analgesia Administration
timeFrame: 3 hours post analgesia administration
measure: To Evaluate the Number of Participants with Pain 4 hours After Analgesia Administration
timeFrame: 4 hours post analgesia administration
measure: To Evaluate the Number of Participants with Pain 5 hours After Analgesia Administration
timeFrame: 5 hours post analgesia administration
measure: Number of Participants with Treatment Related Adverse Events on both arms
timeFrame: Time of first analgesia administration to 2 hours Post Delivery
Secondary outcomes:
measure: Participants with Good Service Satisfaction
timeFrame: First 5 hours Post Delivery
measure: Analgesia Administration to Delivery interval
timeFrame: First 2 hours Post Delivery
measure: Apgar Scores of the Neonates
timeFrame: At first and fifth minutes after birth
measure: Special Care Baby Unit Admissions
timeFrame: First 2 hours Post Delivery
Other outcomes:
Locations:
Study officials:
affiliation: Federal Medical Center, Yenagoa Bayelsa State Southern Nigeria
name: Andrew Orhorho
role: PRINCIPAL_INVESTIGATOR
References: