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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07394491
Enrollment
189
Registered
2026-02-06
Start date
2022-11-01
Completion date
2023-02-25
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Duration

Keywords

Labour duration, intramuscular tramadol, intravenous paracetamol

Brief summary

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

Detailed description

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.

Interventions

DRUGparacetamol

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

DRUGTramadol hydrochloride

100mg of tramadol given in active phase of labour

Sponsors

Federal Teaching Hospital Abakaliki
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean duration of first, second and third stage of labour12 hoursthe mean of the different stages of labour as well as the total duration of labour

Countries

Nigeria

Contacts

PRINCIPAL_INVESTIGATORAssumpta N Nweke

ST Patrick Mission Hospital, Mile $ Abakaliki, Ebonyi State

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026