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

NCT07394491 | Completed

• 1 other identifier: RE/M4H/86/22
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Conditions

Labour Duration

Keywords

Labour duration; intramuscular tramadol; intravenous paracetamol

Outcome Measures

Primary Outcomes (1)

• Mean duration of first, second and third stage of labour

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

  12 hours

Study Arms (2)

intramuscular tramadol

ACTIVE COMPARATOR

100mg of tramadol was given intramuscularly in active phase of labour

Drug: Tramadol hydrochloride

paracetamol

EXPERIMENTAL

1000mg of paracetamol given intravenously in active phase of labour

Drug: paracetamol

Interventions

Tramadol hydrochloride DRUG

100mg of tramadol given in active phase of labour

Also known as: tramadol

intramuscular tramadol

paracetamol DRUG

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

Also known as: acetaminophen

paracetamol

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Spontaneous active phase labour
• No contraindication to vaginal delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Assumpta Nnenna Nweke

Abakaliki, Ebonyi State, 480, Nigeria

Location

MeSH Terms

Interventions

Acetaminophen; Tramadol

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Assumpta N Nweke

  ST Patrick Mission Hospital, Mile $ Abakaliki, Ebonyi State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: November 1, 2022
• Primary Completion: February 25, 2023
• Study Completion: February 25, 2023
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)