Is Buscopan, paracetamol or a combination of both the most effective analgesia for the treatment of non-specific abdominal pain? - Analgesia for NSAP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005395-40-GB

Enrollment

400

Registered

2007-02-26

Start date

2007-05-03

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Adult subjects attending the emergency department complaining of acute abdominal pain MedDRA version: 8.1 Level: LLT Classification code 10000081 Term: Abdominal pain

Interventions

Trade Name: Buscopan Product Name: Buscopan Pharmaceutical Form: Injection* CAS Number: 149644 Other descriptive name: HYOSCINE BUTYLBRO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Potential participants will be those people attending the emergency department complaining of non-specific abdominal pain. To be included they must have acute abdominal pain of 17 years old and 2 on the VAS pain scale. To be included there must not be any obvious surgical or gynaecological diagnosis - the pain must be non-specific in nature. Patients must be stable if they are to be included and must both agree to participate and be able to consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Out of the age range (65 yrs) Any other surgical/gynaecological diagnosis Any signs of instability A confirmed pregnancy Unable to consent or refusal to participate

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary endpoints will be the incidence of side-effects and complications in the 3 different groups;Primary end point(s): The reduction in the pain score in each different group. Pain intensity will be scored at serial times (using the VAS) after medications have been given and the main end-point is looking at which group has a greater reduction in pain intensity; Main Objective: Main objective is to study the analgesic efficacy of Buscopan, paracetamol and a combination of both drugs in the treatment of non-specific acute abdominal pain in the emergency department. Both drugs are routinely used in the emergency department to treat this very common condition. Despite the frequency in which they are used, there is no evidence-based research comparing these drugs and it is not known which is more effective at reducing abdominal pain. Primary outcomes will be the reduction in pain as documented by changes in pain intensity scores at 0 min, 30 min, 60min, 180min. The second primary outcome will be the need for rescue analgesia - the choice of which will be at the physicians discretion.	—

Measure

Time frame

Secondary Objective: Secondary endpoints will be the incidence of side-effects and complications in the 3 different groups;Primary end point(s): The reduction in the pain score in each different group. Pain intensity will be scored at serial times (using the VAS) after medications have been given and the main end-point is looking at which group has a greater reduction in pain intensity; Main Objective: Main objective is to study the analgesic efficacy of Buscopan, paracetamol and a combination of both drugs in the treatment of non-specific acute abdominal pain in the emergency department. Both drugs are routinely used in the emergency department to treat this very common condition. Despite the frequency in which they are used, there is no evidence-based research comparing these drugs and it is not known which is more effective at reducing abdominal pain. Primary outcomes will be the reduction in pain as documented by changes in pain intensity scores at 0 min, 30 min, 60min, 180min. The second primary outcome will be the need for rescue analgesia - the choice of which will be at the physicians discretion.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026