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Completed

NCT Number: NCT07394491

Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour.

It is a well established fact that the pain of labour can be excrutiating and ways to shorten the duration of labour has been sought after. this study compares the role of intramuscular tramadol and intravenous paracetamol in shortening the duration of labour

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Key information

Conditions

Labour Duration

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assumpta Nnenna Nweke

Abakaliki, Ebonyi State, 480, Nigeria

About this study

Background: The excruciating pain associated with labour as led to different studies aimed at finding pharmacolologic and non pharmacologic ways of shortening the duration of labour. Most agents used are either expensive or associated with fetomaternal adverse effects. This has led to the study of paracetamol and tramadol that have analgesic properties and have shown to have effect on labour duration.

Aim: To compare intravenous paracetamol versus intramuscular tramadol in shortening the duration of labour at Alex Ekwueme Federal University Teaching Hospital and St Patrick's Mile 4 Hospital, Abakaliki, Ebonyi State.

Methodology: It is an open label, non inferiority randomized controlled trial that was conducted on one hundred and eighty-nine parturients in active labour. Group A received 1000mg of intravenous paracetamol while Group B received 100mg of intramuscular tramadol and allocation was in the ratio of 1:1. Labour duration in the active phase was noted. Data were analyzed using SPSS version 25.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spontaneous active phase labour
  • No contraindication to vaginal delivery

Exclusion criteria

  • Clinical evidence of cephalopelvic disproportion
  • Malpresentation,
  • Multiple pregnancy,
  • Previously scarred uterus,
  • Preterm labour,
  • Induced labour
  • Antepartum hemorrhage.
  • History of known allergy to tramadol and paracetamol or opioids or
  • History of narcotics dependency.
  • History of renal disease,
  • Fetal distress
  • Intrauterine fetal death.

Treatment and study plan

Paracetamol

Drug

1000 mg of paracetamol was administered intravenously to participants in active phase of labour

Other names: acetaminophen

Tramadol Hydrochloride

Drug

100mg of tramadol given in active phase of labour

Other names: tramadol

Primary outcomes

  1. Mean duration of first, second and third stage of labour

    Time frame: 12 hours

    the mean of the different stages of labour as well as the total duration of labour

Sponsors and collaborators

Lead sponsor

Federal Teaching Hospital Abakaliki

Other Gov

Registry information

Official study title

Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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